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Starrsed Inversa Instructions For Use

1. 84 DES dot rrr 85 16 5 1 Foanin COM aco cp o neon 85 16 6 2 One air bubble random in pipette 86 16 6 3 Large air bubble at the 86 16 7 Quality control trouble 87 17 APPENDIX FOR STARRSED 6 11 nennen nnne 89 18 WORK INSTRUCTION STARRSED INVERSA 107 19 GLOSSARY OF TERMS ttu heuer sn Saee a scc Rx Ex Rune ES x Ex Ep aae aec EE E ANE 125 EE er 127 Page 8 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics Introduction 1 INTRODUCTION The Starrsed Blood Sedimentation Rate Instrument hereafter called Starrsed Inversa is an in vitro diagnostic medical device that automatically carries out the erythrocyte sedimentation rate analysis according to the Westergren method conforming to CLSI approved standard H02 A5 using closed sample tubes filled with citrate or EDTA blood The Starrsed Inversa is an advanced ESR system that offers many unique features and benefits over the traditional ESR procedures Automating this method has the following advantages e The Westergren pipettes are always filled to the correct level
2. DU DR M EDU TUE 27 6 7 2 Menu 1 Sample 27 6 7 3 Menu 2 Patient pos data 0 5 27 6 7 3 1 Menu Patient dla tret E ee tap 28 6 7 3 2 Menu Position data crx m 28 6 7 3 3 Menu Print Bald aote i do caedibus d et amd 28 6 7 3 4 Menu Print raw data M IM 29 6 7 3 5 Menu Send Bala rediret thai eek oda QU VR 29 6 7 4 Menu 3 End of day WES icc acta ient iS acted Sx uid d seh ixi e arbe reped ae 30 6 7 5 Menu 4 PRIME e EE OD 31 6 7 6 Menu 5 Settings User eee ee 32 6 7 6 1 Menu En disable 33 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN Page 5 Document history overview RR Mechatronics p 755 2 Menu Print Settings REM itl pa rad it bap 33 6 7 6 3 Menu Set waste 34 6 7 7 Menu 6 Service User Tc 34 6 7 7 1 Menu Error history Jioc etn ni n ese ERES 34 6 7 7 2 Menu Software Sees 35 6 7 7 3 Menu Displa
3. lt 47 6 8 2 14 Menu Rx etes D eons Or Mi cta 48 6 82 15 Men CHECKSUM E 48 6 8 2 16 Menu 49 6 8 2 17 Menu 30 minute 49 6 8 3 Menu 6 Service Lab Supervisor 49 6 8 3 1 Menu Motor CO 50 6 8 3 2 Menu Valve CODO Mp 51 6 8 3 3 Menu Sensor status aia iic eias oet 51 6 8 3 4 Menu Measure enne 51 6 8 3 5 Menu Read barcode optima etre item tne nn 52 6 8 3 6 Menu Replace pipette 52 6 8 3 7 Menu Empty pipette a tentata 52 6 8 3 8 Menu Empty all 53 6 8 3 9 Menu Empty sample 24121 42 53 7 QUICK START UP Q 54 7 1 Mr ENEE NER 54 DEC sl E A E R 54 7 3 Printer paper replacements rissies
4. E61 62 57 E58 59 60 E Check connection between Starrsed Inversa and LIMS Nack received after Check protocol sending request settings Check LIMS settings No host response after Check protocol sending result settings Check LIMS settings Check connection between Starrsed Inversa and LIMS Starrsed Inversa Instructions For Use Page 95 Version 1 10 MRN 144 EN RR Mechatronics Appendix for Starrsed Inversa Nack received after Check protocol sending result settings e Check LIMS settings selected settings 7 wumbernotassione SCS Numbernotassined _ Numbernotassined E70 Prime error No diluent flow e Check diluent Leakage of tubing nozzle and or detected during priming of bottle pipette tube T1 O 8 9 Check for leakage Blockage leakage in tubing causes air pipette nozzle bubbles Check for Incorrect nozzle adjustment blockages in Blood detection sensor malfunction tubing e Adjust nozzle E71 Unknown status in prime If this error occurs repeatedly contact routine local service engineer Pipette is filled with a sample Prime is only allowed when the pipette is empty E72 Prime Diluent not allowed Pipette not empty Prime Cleaning Solution Pipette is filled with a sample Prime is not allowed Pipette not empty If this error occurs repeatedly contact E74 Error in prime routine gt ab
5. EE 15 2 1 3 15 2 1 4 CID 15 2 2 Technical specifications 16 2 2 1 CE Mark Starrsed Inversa eet rb Uo 18 2 9 JADOBSSOFBS RII a ee ee ee eee 19 3 GENERAL SAFETY es 20 Si Safety WANN em ETE 20 4 INSTALLATION es 21 B LABELS AND STICKEHS eerie te oe Rate epa em Ec ur bna ES EE tees UE ERR IU uS IIR Se LU EINE AREE 21 5 1 Stickers for the onboard reagents 21 6 c M 22 6 1 Navigating through the 23 6 2 Olar UP SGre GN mo r mST 23 6 2 1 Start Printout after Switch ON iiu ceo eri reete eh rrt uci rn ai 24 6 3 Warning screen Prime met t o o 24 6 4 Warning screen End of day 7 eene 25 6 5 Menu structure Main menu Starrsed Inversa 25 6 6 Menu structure User and Supervisor Overview Starrsed Inversa 26 6 7 User menu SEC HOM E 27 6 7 1 Main
6. Date c c Cancel print job m ESC ZEE SELECT Press ENTER to start the function Use these functions to print all sample results from the selected day on the build in printer Page 28 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics User interface Menu DATE Enter the day number and press ENTER Then continue in the same way with the month and year Note When there is no input during 60 seconds the input option is closed 6 7 3 4 Menu Print raw data Print raw data 1 Print data 2 Print graph D ESC AE SELECT Use these functions to print the raw measurement data of a particular sample The raw data can be used to analyse a sample in detail in case of unexpected results Menu PRINT DATA Put the sample tube into the needle holder and press ENTER to get the patient ID from the barcode label or enter the ID manually only numeric input and then press ENTER Menu PRINT GRAPH Put the sample tube into the needle holder and press ENTER to get the patient ID from the barcode label or enter the ID manually only numeric input and then press ENTER 6 7 3 5 Menu Send data Send data Today s results Yesterday s results Single result Date c 5 SELECT Starrsed Inversa Instructions For Use Page 2
7. enii 55 7 4 Liquid levels and reagents preparation 56 7 4 1 Diluent QRR 57 7 4 2 A Glean QRR 010946 tern ette trud qu Rp 57 7 5 Warning screen End 22222 57 Page 6 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics Contents 7 Priming the fluid SySEBITI bin en NU 58 B SAMPLE ROUTINE PROCEDURE nnmnnn nnana 59 8 1 eT cR TT 59 8 2 Placing sample tubes on the needle system 59 8 2 1 Sample tubes with 59 8 2 2 Sample tubes without barcode 2 60 8 3 Aspirating the sample ien o eim PEU ow tinea aw eats 60 8 4 Aborting the sample 4444 4444 000 61 8 5 Automatic rinsing of the sample 00000 61 86 Fill errors e v an tU US EU EUER X RA UD but EUM 61 9 QUALITY CONE et 62 9 1 Monitoring measurement quality with Starrsed 62 Ima tu eu quac esa CI MES 62 9 3 E
8. eee ee jJmsectsampenedecond on 10 Check __ Oheckwaste tube condition Replace __ Replace nozzle O ring and pipette sealing ring f Replace seating boek f f Replace jRepaedikfter oO o o o Replace jRepaewatetbe fT Starrsed Inversa Instructions For Use Page 105 Version 1 10 MRN 144 EN RR Mechatronics Appendix for Starrsed Inversa Level 2 Level 1 n Once a Level 4 Level 3 Article number Article description week 30 days 90 days QWLV050016 O ring 2 9x1 78 Nozzle 77717771 QWLV050004 Pipette sealing ring o X Page 106 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics Work instruction Starrsed Inversa 18 WORK INSTRUCTION STARRSED INVERSA Work instruction section Starrsed Inversa Instructions For Use Page 107 Version 1 10 MRN 144 EN RR Mechatronics Work instruction Number 400 Page 1 of 1 Purpose Daily maintenance Safety Bio Hazard area Instrument Starrsed Inversa Revision Draft September 2010 Prepare disinfectant if not already prepared Add 10 ml bleach sodium hypochlorite to 190 ml de ionized water 5 solution This disinfectant is for cleaning of all external parts that are exposed to blood 1 Wipe the lower tube hol
9. Replace Needle sealing block Open needle cover to get access to the needle Remove both Knurled screws Push the needle down friction possible Place screw in needle sealing block BANG049002 Page 114 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics Pull needle sealing block out the needle guide block assembly Remove screw Place new Needle sealing block BANG049002 Stick the needle in the needle sealing block on the needle not completely through Be aware for biohazard Place the needle sealing block into the needle guide block Push the needle back upwards against the friction Starrsed Inversa Instructions For Use Page 115 Version 1 10 MRN 144 EN RR Mechatronics Push needle up till it is lined up to the mounting fix position Place both Knurled screws Replace Needle cover After the assembling is finished the needle need to be set into the correct position in the needle sealing block Page 116 Insert an empty sample tube into the needle assembly Return to the main screen and go to the sample screen type a number for the patient ID ress B SAMPLING and press 7 CANCEL key which stops the sampling The needle is now correct located in the needle sealing block Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics
10. 86 G General error procedure 83 GENERAL SAFETY INSTRUCTIONS 20 H Hazy 125 Host 125 INSTALLATION 21 INSTRUMENT DESCRIPTION 12 INTRODUCTION 9 INVERSA SYSTEM MESSAGES 78 IVD 125 L Lab Supervisor menu section 38 LABELS AND STICKERS 21 Large air bubble at the bottom 87 Leaking pipettes 84 Level 3 maintenance 80 81 Level 4 maintenance 80 81 Limitations 62 Liquid levels and reagents preparation 56 Main menu 27 MAINTENANCE 80 Menu 1 Sample Mode 27 Menu 2 Patient pos data 38 Menu 2 Patient pos data User 27 Menu End of day wash 30 Menu 30 min method 40 Menu 30 minute output 49 Menu 4 Prime 31 Menu 5 Settings Supervisor 39 Menu 5 Settings User 32 Menu 6 Service Lab Supervisor 49 Menu 6 Service User 34 Menu 7 Card amp Credits User 36 Menu ACK NACK 49 Menu Baudrate 48 Page 127 Index Menu Bottle alarm OFF 36 Menu Carousel position 45 Menu Checksum 48 Menu Date Time 46 Menu Delete data 38 Menu Display S N 36 Menu DST 45 Menu EDTA mode 41 Menu Empty all pipets 53 Menu Empty pipette 52 Menu Empty sample pipets 53 Menu En disable pipet 33 84 Menu Error history 34 Menu ESR time min 47 Menu Language 46 Menu Load credits 37 Menu Measure pipette 51 Menu Motor control 50 Menu Patient data 28 Menu Pos
11. 9 Number not assigned If this error occurs repeatedly contact local service engineer If this error occurs repeatedly contact local service engineer If this error occurs repeatedly contact local service engineer Unknown status in motor Reset the instrument If this error occurs repeatedly contact initialization routine local Service engineer E51 Error in motor initialization Reset the instrument If this error occurs repeatedly contact routine gt aborted local service engineer E52 Filling motor timeout e Filling motor malfunction e Filling motor jammed 4 5 6 7 8 9 0 1 2 3 4 5 6 7 8 50 Page 94 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics o Appendix for Starrsed Inversa Needle motor timeout Needle motor or sensor malfunction Needle motor jammed Carrousel motor timeout Carrousel motor or sensor malfunction Carrousel jammed Gripper motor timeout Gripper motor or sensor malfunction Gripper jammed Measuring motor timeout Measuring motor or sensor malfunction Nozzle motor timeout Number not assigned e Measure head jammed e Nozzle motor or sensor malfunction e Nozzle jammed Power supply current trip e Check power supply Unknown status in protocol If this error occurs repeatedly contact routine local service engineer No host response after e Check protocol sending request settings Check LIMS settings
12. Gripper sensors malfunction e Measuring motor home sensor malfunction Carousel could not turn Nozzle not at home position e Nozzle sensors malfunction Filling motor pulse disk No pulses were detected Position of error filling motor unknown e Pulse disk malfunction e Filling motor jammed or malfunction Starrsed Inversa Instructions For Use Page 93 Version 1 10 MRN 144 EN RR Mechatronics Appendix for Starrsed Inversa Number not assigned Not possible to open or close gripper Carousel is not at a defined position Carousel home sensor malfunction Not possible to move the measure head Carousel is not at a defined position Carousel home sensor malfunction Not possible to move Nozzle up or down Carousel home sensor malfunction Carousel is not at a defined position Needle current too high Sample tube placed incorrectly Needle motor malfunction Needle motor jammed SS E4 Unknown status in If this error occurs repeatedly contact measure routine local service engineer ay Ss Pipette is filled with sample but not ready for measurement It is not allowed to measure the pipette Error in measure routine gt aborted Number not assigned Number not assigned Unknown status in rotate routine Error in rotate routine gt aborted Number not assigned Number not assigned
13. Transfer error Try again or use Software failed to transfer credits from correct chip card or to a service card e Infinite credits can not be transferred Only service cards can be used to transfer credits Communication error with service card Try again or use other service card E121 Number not assigned Number not assigned Number not assigned 124 Number not assigned Number not assigned Number not assigned Number not assigned Number not assigned 129 Number not assigned 71 If this error occurs repeatedly contact local service engineer E135 Number not assigned E136 Number not assigned If this error occurs repeatedly contact local service engineer If this error occurs repeatedly contact local service engineer If this error occurs repeatedly contact local service engineer E130 Internal error If this error occurs repeatedly contact local service engineer Starrsed Inversa Instructions For Use Page 99 Version 1 10 MRN 144 EN RR Mechatronics Appendix for Starrsed Inversa E137 Number not assigned 5 140 The used Starrsed Control Check expiry Use a new batch of Starrsed Control is out of date date Check date time settings E141 Result is out of range the Take a new If results are continuously out of range applicable values for the Starrsed Control but the statistics show identical stable acceptable range depend sample nor
14. 5 SELECT To return to the previous settings screen press ESC To return directly to the Main menu keep ESC pressed until the Main menu is displayed 6 8 2 1 Menu 30 min method lt lt 30 minute output Setting OFF Select B7 When this setting is ON the pipettes are measured after 30 minutes instead of 60 minutes The obtained reading is converted to a predicted 60 minute result Use the ARROW DOWN or ARROW UP keys and select the required option Then press ENTER to save the new setting Page 40 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics User interface 6 8 2 2 Menu EDTA mode lt lt EDTA mode Setting ON select 4 Use the ARROW DOWN ARROW UP keys and select the required option Then press ENTER to save the new setting N NOTE A small hardware modification is necessary to switch between EDTA mode and Citrate mode See work instruction WI 405 on page 124 for details 6 8 2 3 Menu Temperature lt lt Temperature gt gt Current 21 Input The displayed value is the temperature according the build in thermometer of the Starrsed Inversa 1 Check the room temperature near the pipettes with a room thermometer 2 Enter the measured temper
15. data End of day wash Prime Settings Service Card amp Credits 2 se B sevect 6 7 2 Menu 1 Sample Mode SAREL Inver sa ID Ready EDTA P19 01 09 2014 22 Sampling The sample screen shows the current sample ID and status 6 7 3 Menu 2 Patient pos data User Patient pos data Patient data Position data Print data Print raw data Send data Ese BBE SELECT Starrsed Inversa Instructions For Use Page 27 Version 1 10 MRN 144 EN RR Mechatronics User interface 6 7 3 1 Menu Patient data lt lt Patient data gt gt ID Next Use this function to check the sample status of a particular patient in the data storage of the Starrsed Inversa Put the sample tube into the needle holder and press ENTER to get the patient ID from the barcode label or enter the ID manually only numeric input and then press ENTER 6 7 3 2 Menu Position data lt lt Position data gt gt Pipet number 14 Pipet empty Use this function to check the status of a particular pipette Use the ARROW UP and ARROW DOWN keys to scroll through the pipettes 6 7 3 3 Menu Print data Print data Today s results Yesterday s results
16. detection 50 0 Meniscus detection hazy gt 25mm 1025 25 hazy 10mm 10 lt 3mm 3 celis p 100 clear 11 hazy lt 10 dynamicaly determined 3 2 22332 19 out off arca pipet column bottom sedimentation 110mm height Graphic showing typical absorption values of a sample Starrsed Inversa Instructions For Use Page 11 Version 1 10 MRN 144 EN RR Mechatronics Instrument description 2 INSTRUMENT DESCRIPTION The Starrsed Inversa is a semi automatic ESR instrument The blood sample tubes must be mixed externally before they are loaded into the sample holder one at a time The instrument can be configured to work with pre citrated samples Citrate mode or with EDTA anticoagulated samples EDTA mode The sodium citrate dilution takes place a 4 1 ratio and is achieved with 3 accuracy Twenty four Westergren pipettes are housed in the carousel Each is of precision bore glass The fill line is back flushed with sodium citrate diluent Positive sample identification is achieved with a barcode reader and takes place before aspiration of the sample The temperature is corrected to the standard value of 18 and ESR s may be read after one hour or 30 minutes A predicted one hour result is presented in the 30 minute mode Results of the test are expressed in millimeters and printed on the build in printer The Starrsed Inversa can be interface
17. e Print head too hot e Printer malfunction e Voltages out of range If this error occurs repeatedly contact local service engineer e Printer too slow E208 Number not assigned E209 Number not assigned E210 Warning Not possible to rinse Needle not in up position e Needle unit malfunction E211 Warning Last prime too Prime system Last prime more than 12 hours ago long ago E212 Warning Last sample too Start End of day Last sample more than 12 hours ago long ago wash Clean system It is not possible to start rinsing needle might be in sample tube Number not assigned Number not assigned Number not assigned Number not assigned Starrsed Inversa Instructions For Use Page 101 Version 1 10 MRN 144 EN RR Mechatronics Appendix for Starrsed Inversa Appendix Tube connection Starrsed Inversa BANG Tubing Overview _ n Not in tubing set BANGO79200 X CL een 8 Y Page 102 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics Appendix Default settings Starrsed Inversa Appendix for Starrsed Inversa Menu text Setting Menu Client settings 30 MIN METHOD Lab supervisor OFF OFF EDTA MODE Lab supervisor ON ON TEMPERATURE Lab supervisor room temperature r
18. e Using closed sample tubes reduces the possibility of contamination for the user and environment e Standard glass Westergren pipettes are used in which the measurement can be corrected to constant temperature 18 Celsius Even small ab normalities can be detected over a longer period of time irrespective of where and when the blood sample was taken e Every sedimentation measurement is directly linked to an identified sample so that a manual work sheet is unnecessary Patient ID errors are reduced to a minimum by using the bar code reader e Inthe EDTA mode the accuracy of dilution of EDTA blood with citrate is considerably better than manual dilution achieved either by tipping off or using evacuated blood collection tubes pre filled with citrate solution e The data can be send to your Lab Information System e Minimum sample volume is 1 2 ml for the Starrsed Inversa e The Starrsed Inversa can use a variety of closed tubes from different manufacturers 1 1 Explanation of available documentation Manuals for the Starrsed Inversa are available on three levels for the operator the supervisor and the service engineer The following manuals are available 1 Instructions for Use IFU Intended for the operator Contains instructions for normal operation safety preventive maintenance and trouble shooting procedures to solve the most common problems Available in several languages 2 User Manual UM Intended for the la
19. the warning CONTROL OUT OF RANGE 9 6 2 QC Error messages The general ESR errors and warnings are also applied on the QC results see ESR Error and Warning code messages When the result is within range no message is shown When the result is out of range an error message is shown Page 64 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics Quality control sTARSED 24 141 E Press ESC to continue lt lt SAMPLE MODE gt gt Control out of range Continue Press ESC to keep this warning active press Enter to ignore this warning Message when the general setting Temperature Correction TCorr is switched ON e E141 The uncorrected and the corrected result are out of range Messages when the general setting Temperature Correction TCorr is switched OFF The software always calculates a temperature corrected result because only temperature corrected results can be compared with the Assay mean value e E141 The uncorrected and the corrected result are out of range e E142 The uncorrected result is out of range but the corrected result is within range e E143 The uncorrected result is within range but the corrected result is out of range See also Quality control trouble shooting on page 87 The message CONTROL OUT OF RANGE will be shown until a correct
20. 144 EN RR Mechatronics User interface The function may be cancelled by pressing Prime CANCEL Press ENTER to continue Busy please wait Cancel Prime Are you sure M Escape Prime YES Cancel led wait Cancel When the last prime function is more then 12 hours ago a PRIME warning is shown on the display with the recommendation to activate the PRIME function 6 7 6 Menu 5 Settings User Settings En disable pipet Print settings Set waste sensor wh ese Eu Page 32 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics 6 7 6 1 Menu En disable pipet User interface lt lt En disable pipet gt Pipet number 19 Pipet empty 10X000000000012 13000000X0000 024 E The status of the current pipette is shown at the top The lower part shows a representation of all pipettes in the carousel counted from left to right and from top to bottom Enabled pipettes are marked with a dot O disabled pipettes are marked with a cross X The Starrsed Inversa checks automatically for leaking pipettes by comparing the column height measured directly after the aspiration with the column height obtained during the final measurement Le
21. QC result is performed or this message is ignored with continue When this warning is kept active no patient samples can be performed Depending on the users Quality Control Procedures patient samples can be or cannot be performed after a QC Error message Starrsed Inversa Instructions For Use Page 65 Version 1 10 MRN 144 EN RR Mechatronics Turn off 10 TURN OFF It is recommended to turn the Starrsed Inversa off at the end of the day Before the instrument is turned off it is good practice to carry out the Daily maintenance or at least the End of day wash procedure This will help to keep the instrument clean and almost free of bacterial growth for a period of days 10 1 End of day wash procedure The purpose of this function is to clean the inside of the pipettes from residue which may have accumulated over time In the Main Menu use the function END OF DAY WASH This function takes ca 30 minutes to complete All pipettes are automatically filled with X Clean When the last pipette was filled the pipettes are emptied again The function may be aborted by pressing the CANCEL key If the function was aborted the X Clean may not have had enough opportunity to soak and clean the pipettes Page 66 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics Waste disposal 11 WASTE DISPOSAL The waste container has a level sensor and as soon as the level sensor generates a wa
22. keyboard e Scroll to row 7 NEXT using the arrow keys and press ENTER e When the cursor is on row 7 NEXT scroll further down with ARROW DOWN To leave these menus you can Press ESC to return to the previous screen e When the cursor is on the top row 1 scroll further up with ARROW UP to return to the previous screen Keep ESC pressed for 2 seconds to return directly to the main menu The access depends on the use of the appropriate chip cards 6 2 Start up screen inversa The start up screen is shown for approx 5 sec after the Starrsed Inversa is switched on The software version appears at the bottom of this screen Starrsed Inversa Instructions For Use Page 23 Version 1 10 MRN 144 EN RR Mechatronics User interface 6 2 1 Start Printout after Switch ON When a card type A E or a Q card is present in the card reader of the Starrsed Inversa the following information will be printed after Switch ON Example of a print out after switching the Starrsed Inversa ON Column 1 Column 2 Column 3 StaRRsed Inversa24M Line 1 123456789ABC Line 2 30 06 2011 09 00 45 Line 3 Dealer Code 1234567 Line 4 D factor 0 Line 5 Credits Line 6 Total counts Line 7 Serv count 123456A00087 123456Q00002 Line 8 In line 8 the serials numbers of the used cards are displayed 6 3 Warning screen Prime Prime Last Prime more than 12h ago Pr
23. layer of air bubbles that is concentrated on top of the blood column does not affect the sedimentation process itself The sedimentation develops normally below the bubbles However too many bubbles bring about a shortening of the effective blood column which is a deviation from the Westergren method A layer of bubbles up to 5 mm No message Normal ESR result is reported A layer of bubbles from 5 to 25 mm ESR warning 6 Bubbles on top Results should be reviewed before release A layer of bubbles larger than 25 mm ESR Error 3 Too many borders found No ESR result is given 1 Check that tube connections are not leaking 2 Check the fill nozzle condition e Inspect for any cracks or deep scratches in the base that holds the fill nozzle washer or O ring 3 Check for air in diluter system Starrsed Inversa Instructions For Use Page 85 Version 1 10 MRN 144 EN RR Mechatronics Trouble shooting 16 6 2 One air bubble random in pipette When air bubbles are seen after filling This can be caused during preparation of the sample If the sample tube is not mixed or inverted well air can arise in the blood This causes an air bubble occurs in the pipette According to the ICSH a sample should be gently inverted at least eight times Do not shake the sample 16 6 3 Large air bubble at the bottom 1 Check diluter syringe 2 Check Diluent bottle 3 Insufficient or no sample volume A large air bubble a
24. mixing for 30 seconds at least 12 complete inversions Avoid foaming DO NOT VORTEX NOTE To ensure consistent and reproducible results the Control material must be thoroughly mixed and handled in the same manner each time 3 Place Starrsed Control tube immediately after mixing into the analyzer 4 Start the Sample mode The Starrsed Control sample is processed in the same manner as a patient sample Depending on the settings in QC settings a request and or result is send to the LIMS 5 Restore tube after each use at 182309 For detailed information see the Starrsed Control Package Insert The contents of one tube of 5ml is sufficient for three Control samples Do not mix residual material with material from other tubes Do not re use empty tubes See chapter QC Error messages for handling QC errors Starrsed Inversa Instructions For Use Page 63 Version 1 10 MRN 144 EN RR Mechatronics Quality control If the QC sample is out of range the message CONTROL OUT OF RANGE appears This warning is also given when patient sampling is started Press ESC for aborting patient sampling press ENTER to continue sampling It depends on the general QC procedure of the Lab if it is allowed to perform patient samples after the warning CONTROL OUT OF RANGE Starrsed Control should be disposed of as medical waste 9 6 QC Results The measured QC results are compared with the Assay mean value and the acceptable range The applica
25. of chip card Open the printer and check if enough paper is available Replace if necessary Empty the waste container Check the liquid levels and refill the containers if necessary pepe us Page 54 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics Quick start up 7 3 Printer paper replacement When a red line appears across the length of the printout the printer paper roll is approaching its end The remaining paper is sufficient for ca 24 printed reports The red line marker is getting more intense as it comes closer to the end of the paper roll To open the printer pull the handle at the top of the flap Insert a new paper roll as shown Starrsed Inversa Instructions For Use Page 55 Version 1 10 MRN 144 EN RR Mechatronics The liquid levels on the Starrsed Inversa are automatically checked by sensors To avoid level sensor alarms during routine operation the liquid levels in the containers should also be checked visually every day Quick start up 7 4 Liquid levels and reagents preparation NOTE Refill reagent as soon as possible wani the level sensor alarm appears The audio alarm can be disabled with 4 SERVICE BOTTLE ALARM stay in this menu option during refilling the bottle s 1 Reagents preparation e Use only the reagent containers which are supplied with the Starrsed Inversa e To open the bulk reagent packages remove the perforated flap from
26. shown on the instrument type label on the back of the Starrsed Inversa 6 7 7 4 Menu Bottle alarm OFF lt lt Bottle alarm OFF gt gt Use this function to temporarily turn off the buzzer during a bottle alarm e g diluent bottle empty or waste bottle full 6 7 8 Menu 7 Card amp Credits User Card amp Credits 1 Load credits 2 Read service card C C C Fe Ese mE SELECT Page 36 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics User interface Select 1 LOAD CREDITS credits continue and press ENTER to start the function This function is used to load credit units from a credit chip card into the internal memory of the Starrsed Inversa Select 2 READ SERVICE CARD continue and press ENTER to start the function This function is used to unlock the protected menus and functions 6 7 8 1 Menu Load credits lt lt Load credits gt gt lt lt Load credits 2 SS Load credits gt gt Done Type Continue Do NOT remove card SN 1234567899 Busy please wait Credits cE a YES a ves E When credits are stored in the Starrsed Inversa the new information is shown This is the total amount of available credit units in memory This is the code letter for the type of chip card SN This is t
27. their own acceptable range for Starrsed Control ABNORMAL range can be set from a minimum of 2 mm to a maximum of 15 mm Numbers outside this range cannot be saved Page 42 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics Note It is advised to use the default assay ranges Use caution when setting the custom ranges A too narrow range may cause unjustified rejection of QC sample results subsequent rejection of patient results and undue burden on maintenance User interface 4 QC REQUEST TO LIMS e ON A sample request for the QC sample is send to LIMS The QC sample will only be processed if the LIMS responds with YES Use this setting if the ESR result of the QC sample will be send to LIMS as well and LIMS requires that all samples are requested first If the QC sample is linked with a Lab ID the sample will be requested at LIMS with the Lab ID If the QC sample is used with the original Starrsed Control sample ID the sample will be requested at LIMS with the Starrsed Control sample ID e OFF Default setting All QC samples will be processed without requesting at LIMS 5 QC RESULT TO LIMS e ON QC results are send to the LIMS as a standard ESR result If the QC sample is linked with a Lab ID the result will be send to LIMS with the Lab ID If the QC sample is used with the original Starrsed Control sample ID the result will be send to LIMS with the Starrsed Control sample ID Note W
28. 9 Menu Empty sample pipets This function can be used to empty all filled pipettes due to an error condition Press ENTER to confirm the selection and start the function lt lt Empty sample pipets gt gt lt lt Empty sample pipets gt gt Samples will be lost Are you sure E Press ENTER to continue Starrsed Inversa Instructions For Use Page 53 Version 1 10 MRN 144 EN RR Mechatronics Quick start up 7 QUICK START UP This section describes a quick start up procedure and a general description of what to do before starting a large batch of samples to run through the system 7 1 Power up sequence Switch ON procedure e Switch the Starrsed Inversa ON e Wait until the Main menu is visible on the display e The instrument is now ready 7 2 Check list The laboratory supervisor should check the following instrument settings and select the required options Menu SETTINGS 30 MIN METHOD Default is OFF Menu SETTINGS EDTA Default is ON e Menu SETTINGS TCORR temperature correction Default is ON NOTE A small hardware modification is necessary to switch between EDTA mode and Citrate mode See work instruction WI 405 on page 124 for details Check the following things before each large batch of samples Ensure that a chip card is present in the card reader This may be any type
29. 9 Version 1 10 MRN 144 EN RR Mechatronics User interface Menu TODAY S RESULTS and YESTERDAY S RESULTS Press ENTER to start the function Use these functions to send all sample results from the selected day to the HOST Menu SINGLE RESULT Enter Patient ID select the required result in case of more than one result with ENTER To send one result to the HOST press START Menu DATE Enter Day Month Year and results will be send to the HOST 6 7 4 Menu 3 End of day wash End of day wash Cont i nue YES lt Escape Press ENTER to start the function Page 30 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics User interface The function may be cancelled by pressing End of day wash CANCEL Busy please wait ar Cancel End_of_day wash Press ENTER to continue Are you sure Escape End of day wash YES Cancelled wait Cancel When the last sample is more than 12 hours ago an END_OF_DAY WASH warning is shown on the display with the recommendation to activate the END_OF_DAY WASH function 6 7 5 Menu 4 Prime Prime Continue YES Press ENTER to start the function Starrsed Inversa Instructions For Use Page 31 Version 1 10 MRN
30. Check the values of the waste sensor at Menu Set waste sensor Page 78 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics Data safety management 14 DATA SAFETY MANAGEMENT All data in the Starrsed Inversa is stored in a battery backup memory This means that all raw data and results are kept irrespective of a power failure or if the instrument is un intentionally turned off After the start up procedure the software checks whether there are any ESR s still outstanding If so these will be carried out first After a power failure the sedimentation time 60 or 30 min may be exceeded However the start time is saved and therefore the actual sedimentation time can be checked A limited amount of sample data can be stored see Technical Specifications 14 1 Power failure If a power failure occurs it is recommended that the Starrsed Inversa is switched OFF by the power switch When the power returns the instrument can be switched ON After the standard start up process the Starrsed Inversa will continue to process the remaining samples Starrsed Inversa Instructions For Use Page 79 Version 1 10 MRN 144 EN RR Mechatronics Maintenance 15 MAINTENANCE The Starrsed Inversa is an analyzer that operates with considerable amounts of whole blood virtually undiluted and stores it in a pipette for one hour For this reason instrument maintenance is of the utmost importance To maintain the maximum re
31. GOA40031 Drip plate front BANGO49002 sealing block Tues 00000000 079031 31 Only to be used for Citrate Mode BANG110141 Inversa 24M User manual O m A o m c o RV o 5 c D lo Serial Cable SUBD9 male female QEDV130017 Fuse 1 6 A Slow 220V QEDV130019 Fuse 2 5 A Slow 115V 080100 Thermal Roll 57 x 47 x 12 mm O m e e i i Teflon tip repair set 1 ring Disc filter 25mm White for waste container QWLV050003 O ring 1 5x1 for fill nozzle and mixing coil 5 i i 24V Q CO o e o 2 5 a Q D S QWBM050014 Retaining Washer 1 5 for pipettes Orno z978 tortino Tube or persans 7 7 BaNG912560 Meearonesiermensshpead O O O O BANG91256 MeeharonesisrumensehpewdS ABEBEREEE B B E 90 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics Appendix for Starrsed Inversa QWLV080002 Quad ring 3 68 x 1 78 for valves BANG110021 Nozzle Calibration jig Starrsed Inversa Instructions For Use Page 91 Version 1 10 MRN 144 EN RR Mechatronics Appendix for Starrsed Inversa Appendix Error list Starrsed Inversa Ere O Rema
32. INSTRUCTIONS FOR USE STARRSED INVERSA INSTRUCTIONS FOR USE Version 1 10 MRN 144 EN Master Registration Number MRN 144 EN RR Mechatronics Masters of Measurement Manufacturer Mechatronics Manufacturing B V Phone 31 229 291 129 Fax 31 229 241 534 E mail support rrmechatronics com Internet http www rrmechatronics com P O Box 225 Postal address 1620 AE Hoorn The Netherlands De Corantijn 13 Office address 1689 AN Zwaag The Netherlands Copyright R amp R Mechatronics International B V All rights reserved Subject to changes without prior notice Issued by the Support Department of Mechatronics RR Mechatronics Document history overview Document history overview MRN 144 EN Published date 10 March 2015 O date 10 March 2015 1 10 March e General safety instructions 2015 NL e Explanation of documentation e New display illustrations e Introduction of QC procedure e Addition of maintenance level information August Inversa Keyboard Single result added 2013 Trouble shooting Appendix e Error 20 and 70 e WI 404 rev 002 January Inversa Keyboard Waste sensor to end user H 2013 part Schavemaker e Waste bottle alarm e Protocol R 3500 Modifications in User H interface Schavemaker May 2011 Introduction e Line The used K Artz sedimentation pipettes are Glossary automatically washed and dried removed e Explanation IVD added February Work instr
33. If a pipette is leaking only slightly this may not be detected by the instrument Individual pipettes can be disabled manually for further use until they can be replaced e Note the number of the leaking pipette e Wait until the pipette is measured and empty Go to Menu SETTINGS EN DISABLE PIPET and follow the instructions on page 33 Starrsed Inversa Instructions For Use Page 83 Version 1 10 MRN 144 EN RR Mechatronics Trouble shooting 16 5 2 Replacing a pipette NOTE Chip card type S is required NOTE Make sure that all pipettes are empty and do need to be measured e Goto Menu SERVICE REPLACE PIPET e Enter the number of the pipette to replace and press ENTER The pipette is turned to the door opening e Open the pipette cap and lift the pipette out Install the new pipette in the reversed order Page 84 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics Trouble shooting 16 6 Air bubbles After a normal aspiration the Westergren pipette must be free of air bubbles In the following examples different patterns of air bubbles which can appear in the pipettes are shown Air bubbles can affect the sedimentation and are mostly reported as errors and no ESR result is reported Usually bubbles are caused by a leakage at the bottom of the pipette If air bubbles are visible in the pipette check the following 16 6 1 Foam in column A
34. RO ume pO la ta 75 2 Aspett Hazy ueri sopa dicun ated rere ae 76 12 2 6 1 Analyser HAZY code messages Tf 13 INVERSA SYSTEM MESSAGES 78 13 1 System messages oasis eiie die auderem pd GE id Pd a d EE 78 14 DATA SAFETY 79 EA RERE EAR 79 15 80 uS cc 80 Starrsed Inversa Instructions ForUse Pager Version 1 10 MRN 144 EN RR Mechatronics Document history overview 15 2 I I sp EEn 80 15 3 Level 4 maintenance soins preci 81 15 4 Level 3 81 16 TROUBLE SHOOTING ees een nee 82 16 1 General error 82 162 221 ET 82 15 3 Column t pum sut uti 82 16 4 Sampling not allowed 2 83 16 5 NEA i 83 16 5 1 Disabling a Nelle iE 83 16 5 2 Replacing a pipette Rau
35. TE PIPET DATA is used to delete all data of samples currently in the pipettes These samples have not been measured yet Function 2 DELETE HIST DATA is used to delete all stored data results of previously measured samples A Page 38 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics User interface lt lt Delete pipet data 2 Samples will be lost Are you sure lt lt Delete hist data gt gt Samples will be lost Are you sure Press ENTER to confirm the selection and start the function 6 8 2 Menu 5 Settings Supervisor Settings En disable pipet Print settings Set waste sensor Next se Next submenu Settings 30 min method EDTA mode Temperature Tcorr QC Settings Carousel position Next ESC ME SELECT Starrsed Inversa Instructions For Use Page 39 Version 1 10 MRN 144 EN RR Mechatronics User interface Next submenu Settings DST Result at limit Printer results Date Time Language ESR time min Next A ESC BE SELECT Next submenu Settings Protocol Baudrate Checksum ACK NACK 30 minute output 7 m E rM
36. TINE PROCEDURE 59 Sample tubes with barcode 59 Sample tubes without barcode 60 Sampling not allowed now 84 Sedimentation measurement principle 11 Starrsed line of ESR instruments 10 Start Printout after Switch ON 24 Start up screen 23 Stickers for the onboard reagents bottles 21 System messages 78 T Technical specifications 16 Temperature correction 63 125 TROUBLE SHOOTING 83 TURN OFF 66 U Unidirectional 126 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics USER INTERFACE 22 User menu section 27 38 W Warning screen End of day wash 25 57 Warning screen Prime 24 Waste container 67 Waste disposal 21 WASTE DISPOSAL 67 Weekly 80 WI 126 WORK INSTRUCTION STARRSED INVERSA 107 X X Clean QRR 010946 21 57 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN Index Page 129
37. Work instruction Number 403 Page 1 of 8 Purpose Level 3 maintenance Safety Bio Hazard area Instrument Starrsed Inversa Revision 001 November 2012 NOTE Chip card type S is required Prepare disinfectant if not already prepared Add 10 ml bleach sodium hypochlorite to 190 ml de ionized water 5 solution This disinfectant is for cleaning of all external parts that are exposed to blood 1 Wipe the lower tube holder of the needle unit 2 Wipe the stainless steel drip plates below the pipette carousel and needle unit 3 In the Main menu use the function END OF DAY WASH Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN Page 117 RR Mechatronics 4 Check the system for leakage 5 Replace waste pump tube 94 6 Inspect sample needle condition Menu SERVICE MOTORCONTROL NEEDLE M31 Press ARROW DOWN twice to expose the needle tips If the tips are worn replace the needle 7 Replace disk filter The disk filter QWLV040001 is the filter which can be found on the waste bottle ER 118 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics Nozzle O ring and pipette seal ring replacement 1 2 mod Note Replace the flat pipette seal ring BANGO030052 and or replace the nozzle O ring QWLV050016 Starrsed Inversa Instructions For U
38. _err hhh www ttt ccc err means it is a limit error e hhh is the 30 minutes ESR e www is the 60 minute ESR ttt is the temperature corrected 60 minute result ccc is the column height Example of a limit error message err 42 84 75 200 means 42 mm in the 30 minute method and temperature correction 75 with a correct column height err 84 75 200 means 84 mm in the 60 minute method and temperature correction 75 with a correct column height NOTE The diluter is mechanically linked with the pipette plunger in the Starrsed Inversa The dilution rate is therefore always 10096 and will never be out of limits 12 2 5 Reporting range The reporting range in the lines 2 3 and 4 are in millimeters The start of the measure range is at the top of the meniscus down to 140 mm If the detection of cells plasma is over 140 mm then the report will be 2140 Starrsed Inversa Instructions For Use Page 75 Version 1 10 MRN 144 EN RR Mechatronics Reporting 12 2 6 Aspect Hazy The automatic reading of the Westergren sedimentation pipettes is carried out by moving an optical sensor along the pipettes While the sensor is moving a reading is made every 0 25 mm The sensor is reading the absorption of infra red light through the Westergren pipette filled with blood From these readings values at a number of absorption levels are determined All absorption figures are relative to the darkest and lightest
39. act aborted local service engineer If this error occurs repeatedly contact local service engineer E111 ATR error Remove chip card Bad or no communication with card e Chip card incorrectly inserted e Wrong type of chip card e Chip card reader malfunction and retry CRC stored in chip card memory Dealer code error Remove chip card Dealer code does not match with dealer and insert correct code set in instrument card Card type error Remove chip card Wrong type of chip card inserted E g and insert correct credit card inserted instead of service chip card card E115 Card not original Remove chip card Inserted chip card is not an origina Mechatronics card Card memory error Remove chip card Updated chip card memory RMA does not match with source Send chip card to dealer for further inspection Card copy error Remove chip card Inserted chip card is copy Original chip card already used to upgrade credits Page 98 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics Appendix for Starrsed Inversa E118 Credit maximum error Remove chip card It is not allowed to upgrade credits Maximum of credits has been reached D factor error Remove chip card It is not allowed to upgrade credits and change D factor e D factor must be between 1 and first 10 000 when A to E chip card is used When Q card is used D factor must be 0
40. aking pipettes are automatically disabled for future use and must be enabled manually Note In this example pipettes 2 and 18 are disabled Use the ARROW DOWN or ARROW UP keys and select the required pipette number then press the ENTER key to toggle the setting to the opposite of the current state lt lt En disable pipet gt Pipet number 21 Disable Are you sure ES mE 6 7 6 2 Menu Print settings lt lt Print settings gt Cont i nue ES YES Starrsed Inversa Instructions For Use Page 33 Version 1 10 MRN 144 EN RR Mechatronics User interface Press ENTER to start the function The instrument settings are printed on the build in printer 6 7 6 3 Menu Set waste sensor lt lt Set waste sensor gt gt Current 201 Waste sensor 199 i Save 019015 019017 CURRENT current setting WASTE SENSOR actual measured value 019015 In case of a new waste bottle If the values do not match press ENTER to save the new setting Value range 130 240 BANGO 1 9017 Value set during installation Value range 190 210 6 7 7 Menu Service User Service Error history Software versions Display S N Bottle alarm OFF ESC SELECT 6 7 7 1 Menu Error hist
41. anation 1 Instrument name Starrsed Inversa 2 Instrument type and model 3 Instrument serial number 4 Electrical information Page 18 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics Instrument description 5 Protection class 6 Manufacturer information and Date of manufacture 2 3 Accessories kit The Starrsed Inversa comes with an accessories kit For a complete list of the the contents of accessories kit see Appendix Article reference list Inversa on page 90 Starrsed Inversa Instructions For Use Page 19 Version 1 10 MRN 144 EN RR Mechatronics General safety instructions 3 GENERAL SAFETY INSTRUCTIONS The instrument described in this manual is designed to be used by properly trained personnel only For the correct and safe use of this instrument it is essential that both operating and servicing personnel follow generally accepted safety procedures in addition to the safety precautions specified in this manual e Execute your work according to this manual Read the instructions before operating the instrument Observe all cautionary markings in the manual and on the instrument Keep this manual for future reference e Follow the bio safety procedures when working with blood contaminated parts cautious to prevent stinging during cleaning or replacing the needle assembly e Repair can only be executed by trained and qualified personnel e Wear protective clothing e W
42. ature from the room thermometer as the current value for the temperature sensor 3 Then press ENTER to save the new setting 6 8 2 4 Menu Tcorr lt lt gt gt Setting ON mE Select Starrsed Inversa Instructions For Use Page 41 Version 1 10 MRN 144 EN RR Mechatronics User interface This option is used to set if Temperature correction is to be applied on the measured ESR results Use the ARROW DOWN or ARROW UP keys and select the required option Then press ENTER to save the new setting 6 8 2 5 QC Settings QC Settings Use assay range Custom NORMAL range Custom ABNORM range QC request to LIMS QC result to LIMS Auto remove link 7 Linked ID s 5 E SELECT In QC settings the following options can be selected 1 USE ASSAY RANGE e The default assay range which is predetermined for the current batch of Starrsed Control is used These ranges cannot be changed in this option Default setting 2 CUSTOM NORMAL RANGE e The lab can establish their own acceptable range for Starrsed Control NORMAL range can be set from a minimum of 2 mm to a maximum of 15 mm Numbers outside this range cannot be saved lt lt Custom NORMAL range gt gt Current 5 Input ES 3 CUSTOM ABNORM RANGE e lab can establish
43. ay number and press ENTER Then continue in the same way with the month year hour and minutes Note When there is no input during 60 seconds the input option is closed 6 8 2 11 Menu Language lt lt Language English 1 4 m EE select Select the required language for the user interface A limited number of languages is available Page 46 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics 6 8 2 12 Menu ESR time min User interface lt lt ESR time min Current 60 Input Es This function can be used to temporarily set a different sedimentation time for service or maintenance reasons Enter the required sedimentation time Then press ENTER to save the new setting NOTE This setting is only active as long as the service chip card is present in the card reader When the chip card is removed the setting is automatically reset to 30 or 60 minutes according the selected method 6 8 2 13 Menu Protocol lt lt Protocol gt gt No serial output 2 3 Select 4 A protocol is a set of rules governing the communication and the transfer of data between machines as in a computer system It is also a formal set of rules and procedures to be followed during a request for information before data is transferred between machi
44. b supervisor Contains information from the IFU and additional information concerning settings service higher maintenance levels and trouble shooting procedures to solve more complicated problems Only available in English 3 Service Manual SM Intended for trained service engineers Describes maintenance servicing and repair of the instrument in detail Contains detailed descriptions of parts assembly drawings modifications extended trouble shooting flow diagrams etc Only available in English Starrsed Inversa Instructions For Use Page 9 Version 1 10 MRN 144 EN RR Mechatronics Introduction 4 Installation Manual IM Intended for trained service engineers Contains instructions and procedures for installation and start up Only available in English Manuals are available in PDF and HTML format and can be downloaded from http www rrmechatronics com 1 2 Starrsed line of ESR instruments The Starrsed line of ESR automated instruments is unique by the fact that it has automated the Westergren Method and fully complies with the published reference method including working with diluted EDTA blood The Starrsed line offers several types of ESR analyzers Our solutions range from tube based to rack based to track based the latter resulting in the highest level of automation possible Laboratories that operate different Starrsed instruments in different capacities are assured that correlations are precise and fully reliable Sta
45. ble values for the acceptable range depend on the user setting See chapter QC Settings on page 42 for more information If applicable the QC result is reported to LIMS using the chosen settings regarding temperature correction display of dilution rate and limit error settings 9 6 1 QC Result analysis QC results can be send to the LIMS and can be processed for further analysis in lab s own Quality Control data system Authorised staff should identify and differentiate acceptable unacceptable random errors and trends and or shifts in systematic errors from the statistical data Depending on the users Quality Control Procedures analytical results could be accepted or rejected Changes in QC results can be gradual or abrupt Gradual changes can be caused by contamination and incidental environmental variations Abrupt changes can be caused by change of QC material batch or possible hardware errors If results are continuously out of range due to significant difference between calculated mean and control value but the statistics show precise results with small deviations it should be considered to expand the acceptable assay range with QC Settings on page 42 If results are incidentally out of range it is advised to perform a daily maintenance and or End of day wash and then perform another QC sample step before releasing patient results It depends on the general QC procedure of the Lab if it is allowed to perform patient samples after
46. ccurs repeatedly contact local service engineer e Flash memory malfunction If this error occurs repeatedly contact local service engineer e Flash memory malfunction If this error occurs repeatedly contact local service engineer e Flash memory malfunction If this error occurs repeatedly contact local service engineer e Flash memory malfunction If this error occurs repeatedly contact local service engineer e Flash memory malfunction If this error occurs repeatedly contact local service engineer e Flash memory malfunction If this error occurs repeatedly contact local service engineer e Flash memory malfunction If this error occurs repeatedly contact local service engineer e Flash memory malfunction If this error occurs repeatedly contact local service engineer e Flash memory malfunction If this error occurs repeatedly contact local service engineer e Flash memory malfunction Page 97 RR Mechatronics Appendix for Starrsed Inversa Mumbermtassped E100 number notassione iNumbernotassines E102 Numbernotassiones i Eros Numbernotassionee E104 O OOOO day wash routine E106 Number notassiones E108 Unknown status in pipette the instrument If this error occurs repeatedly contact test routine local service engineer E109 Error in pipette test routine If this error occurs repeatedly cont
47. d ESR value should be compared with the expected value using temperature correction The calculation of a 30 minute measurement to a 60 minute ESR result with temperature correction influences the QC result See chapter QC Results on page 64 for more information Page 62 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics Quality control 9 5 Quality control procedure Starrsed Control is provided in ready to use sample tubes and is used in the same manner as patient samples Starrsed Control is to be used for the Westergren method with dilution only as prescribed by the ICSH review of the measurement of the ESR 2011 and the CLSI Procedures for the ESR Test Approved standard H02 A5 2011 Citrate mode When the Starrsed analyzer is used in the Citrate mode the Starrsed Control material must be diluted manually by transferring the necessary amount of material into a pre citrated ESR blood collection tube Immediately after re suspending transfer the necessary amount of material into a pre citrated tube according instructions of the tube manufacturer Close the tube with the mixture and invert at least 12 times then place the sample into the analyzer 1 When using LAB ID Link the Lab ID with Starrsed Control Sample ID attach the lab ID label on the tube on top of the original Starrsed Control label 2 Invert the Starrsed Control tube until packed cells have been completely re suspended Continue
48. d bi directional with Laboratory Information Management Systems LIMS through interface protocols developed by Mechatronics The main features of the Starrsed Inversa are Single unit with small footprint housing all units and containers Closed compartment with a carousel holding 24 precision bore glass Westergren pipettes measuring unit and pipette filling station Build in printer e Chip card system e Barcode reader for sample identification e Serial parallel interface e Easy accessible keypad with light key pressure due to piezo technology e Battery backup memory e Accessories kit Page 12 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics Instrument description Starrsed Inversa Instructions For Use Page 13 Version 1 10 MRN 144 EN RR Mechatronics Instrument description 2 1 Chip card system The Starrsed Inversa uses a chip card system which makes it possible to employ the instrument either in a pay per test scheme or on customer owner basis Specific types of chip cards also grant access to specific instruments settings A chip card must always be present in the card reader to operate the instrument The card reader is located on the left side of the Starrsed Inversa Insert the chip card into the card reader with the printed side facing forward The chip card is correctly inserted when it appears as shown in the picture Page 14 Starrsed Inversa Instructi
49. der of the needle unit 2 Wipe the stainless steel drip plates below the pipette carousel and needle unit 3 Inthe Main menu use the function END_OF_DAY WASH 4 Check the system for leakage Starrsed Inversa Instructions For Use Page 108 Version 1 10 MRN 144 EN RR Mechatronics Work instruction Number 406 Page 1 of 1 Purpose Weekly maintenance Safety Bio Hazard area Instrument Inversa Revision 001 November 2012 NOTE Chip card type S is required Prepare disinfectant if not already prepared Add 10 ml bleach sodium hypochlorite to 190 ml de ionized water 5 solution This disinfectant is for cleaning of all external parts that are exposed to blood 1 Wipe the lower tube holder of the needle unit 2 Wipe the stainless steel drip plates below the pipette carousel and needle unit 3 Inthe Main menu use the function END_OF_DAY WASH 4 Check the system for leakage 5 Inspect sample needle condition Menu SERVICE MOTORCONTROL NEEDLE M31 Press ARROW DOWN twice to expose the needle tips If the tips are worn replace the needle Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN Page 109 RR Mechatronics Work instruction Number 404 Page 1 of 6 Purpose Level 4 maintenance Safety Bio Hazard area Instrument Starrsed Inversa Revision 003 December 2014 NOTE Chip card type S is required Pr
50. ds of type T Technician card are used by service technicians to install and prepare the instrument for routine operation and to perform service functions When this type of chip card is inserted in the card reader a PIN code must be entered to unlock the protected menus Starrsed Inversa Instructions For Use Page 15 Version 1 10 MRN 144 EN Instrument description RR Mechatronics 2 2 Technical specifications Technical specifications for the Starrsed Inversa Starrsed Inversa instrument models Model name Catalogue number Model Starrsed Inversa 24M BANG109000 ESR method Westergren method ESR method Temperature compensation method R W Manley J clin Path 1957 10 354 30 minute method R Rogers Medical Laboratory World 1994 Allowed blood specimen types e For EDTA mode Whole blood with 1 EDTA anticoagulant e For Citrate mode Whole blood 4 vols with sodium citrate anticoagulant diluent 1 vol Automatic dilution 4 vols blood 1 vol sodium citrate diluent 3 2 NaCl accuracy 3 Reported result mm after 1 hour Reagents Reagents used QRR 010931 Diluent QRR 010946 X Clean Blood volume Aspirated blood volume per sample 1 2 ml in EDTA mode 1 4 ml in Citrate mode Page 16 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics Version 1 10 MRN 144 EN Instrument description Sample t
51. e and push the START key again 8 2 2 Sample tubes without barcode If the sample tube has no barcode or the barcode can not be read you can enter the sample ID manually 1 Start the SAMPLE MODE 2 Enter the ID number 3 Push START key NOTE U The sampling may not start immediately if a clean pipette is not yet available but will start automatically when a clean pipette is available within 90 sec To prevent the aspiration of a not properly mixed sample sampling will not start automatically when it takes longer than 90 sec for a pipette to become available The operator must then remix the sample and push the START key again 8 3 Aspirating the sample When a clean pipette is available the needle assembly goes down and pushes the sample tube over the needles The necessary blood volume is drawn from the sample tube into a tube T3 until the blood sensor is triggered When the blood sensor is triggered the piston of the Westergren pipette is pulled up to aspirate the sample into the pipette During this fill motion the diluter syringe is driving the diluent via the nozzle into the blood stream NOTE If the Starrsed Inversa is set to bidirectional communication with a HOST and ESR measurement is not required for this sample the message No ESR is shown on the display The sample will not be aspirated and may be removed from the needle unit Page 60 Starrsed Inversa Instructio
52. e screen type a number for the patient ID ress B SAMPLING and press 7 CANCEL key which stops the sampling The needle is now correct located in the needle sealing block Page 123 RR Mechatronics Work instruction Number 405 Page 1 of 1 Purpose Switch EDTA and Citrate mode Safety Bio Hazard area Instrument Starrsed Inversa Revision 001 November 2011 NOTE Settings tab is password protected Settings are only be changed by a Lab Supervisor 1 2 3 and the needle plate Re install the front cover samples Change settings in Menu EDTA mode switch to the OFF status for using citrate blood ON EDTA mode Tube with label number 3 OFF Citrate mode Tube with label number 31 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN Remove the front cover by lifting the clips at the top and bottom and pulling the cover away Disconnect tube with label number 3 from the needle Connect the tube with label number 31 BANGO0790031 between the tube with label number Pull the added length of tubing through the stainless steel plate and store the tubing behind the Page 124 RR Mechatronics 19 GLOSSARY OF TERMS B 19 1 1 1 1 Bidirectional communication means that there is two way communication from the Starrsed Inversa to the HOST sample requests and results and from the HOST to the S
53. e transfer of data between machines as in a computer system It is also a formal set of rules and procedures to be followed during a request for information before data is transferred between machines and computer systems The following protocols can be selected for data transfer to the Laboratory data processor computer No Serial output MECHATRONICS 01 bidirectional MECHATRONICS 02 unidirectional Compact bidirectional Compact unidirectional Protocol Sysmex R 3500 Protocol Sysmex R 3500 unidirectional S D Or qw ls The protocol can be set in menu SETTINGS PROTOCOL After selecting a protocol save the new settings by pressing the ENTER key CHECKSUM ACK NACK 30 MINUTE OUTPUT Serial 2 Not selectable Not selectable Not selectable Serial 3 Not selectable Selectable Not selectable Serial 4 Selectable Not selectable Selectable Serial 5 Selectable Selectable Selectable Starrsed Inversa Instructions ForUse 3 Page69 Version 1 10 MRN 144 EN RR Mechatronics The results of the ESR measurements are send to the built in printer and printed on thermal paper Reporting 12 2 Result Printout The layout of the report depends on the selection of the 60 or 30 minute method NOTE UP Thermal paper is sensitive to light and printouts will start to fade after several weeks If you need to retain the printed reports for future reference store the printouts in a cool dark place or make copies on a regular copy
54. enu DST lt lt DST gt gt Setting ON Select This function is used to switch the internal clock to Daylight Saving Time also called Summertime Use the ARROW DOWN ARROW UP keys and select the required option Then press ENTER to save the new setting Note Can only be set between 03 00 and 21 00 and when the carousel is empty 6 8 2 8 Menu Result at limit lt lt Result at limit Setting ON m me Select 4 Starrsed Inversa Instructions For Use Page 45 Version 1 10 MRN 144 EN RR Mechatronics User interface See section Results at limit errors on page 75 for details of this option Use the ARROW DOWN ARROW UP keys and select the required option Then press ENTER to save the new setting 6 8 2 9 Menu Printer results lt lt Printer results gt gt Setting ON mA ue Select This function is used to switch if ESR results must be printed on the build in printer Printing may not be necessary if all results are send to a HOST Use the ARROW DOWN or ARROW UP keys and select the required option Then press ENTER to save the new setting 6 8 2 10 Menu Date Time lt lt Date Time 09 10 2013 12 23 Day dd Input mM To set the system date and time enter the d
55. epare disinfectant if not already prepared Add 10 ml bleach sodium hypochlorite to 190 ml de ionized water 5 solution This disinfectant is for cleaning of all external parts that are exposed to blood 1 Wipe the lower tube holder of the needle unit 2 Wipe the stainless steel drip plates below the pipette carousel and needle unit 3 Inthe Main menu use the function END_OF_DAY WASH Starrsed Inversa Instructions For Use Page 110 Version 1 10 MRN 144 EN RR Mechatronics 4 Check the system for leakage 5 Check the waste pump tube condition Replace the tube if it appears worn or leaking 6 Inspect sample needle condition Menu SERVICE MOTOR CONTROL NEEDLE M31 Press ARROW DOWN twice to expose the needle tips If the tips are worn replace the needle Starrsed Inversa Instructions For Use Page 111 Version 1 10 MRN 144 EN RR Mechatronics Nozzle O ring and pipette seal ring Replacement 1 2 LI HERD ur 1 Pins Note Replace the flat pipette seal ring BANGOS30052 or replace the nozzle O ring QWLV050016 Page 112 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics o Note Check if all 5 O rings QWLV050003 are in place and or if applicable replace the O rings QWLV050003 Starrsed Inversa Instructions For Use Page 113 Version 1 10 MRN 144 EN RR Mechatronics
56. f the Lab ID is alphanumeric 1 Use asample tube with the correct Lab ID label only numeric values can be entered manually 2 Place the Starrsed Control tube on sample position press Enter to scan the barcode 3 Place the tube with Lab ID on sample position press Enter to scan the barcode The link information is showed on the screen the link is activated lt lt Linked ID s lt lt Linked ID s gt gt lt lt Linked 5 gt Starrsed Control ID Lab ID Starrsed Control ID ID ID QC9FB0AA29 Lab ID 030423 Delete New 1 5 If five links are filled in the first one will be replaced when a new link is added Lab ID which is already used cannot be saved Page 44 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics 6 8 2 6 Menu Carousel position User interface lt lt Carousel position gt gt Current pos 19 Set position Learn positions E These functions are used to reset the correct pipette positions that are stored in memory The displayed value is the pipette number that should currently be present at the nozzle position Press the ENTER or START key to show the Input option Enter the pipette number which is actually present at the nozzle position and press ENTER to activate the action 6 8 2 7 M
57. h X Clean from the 5 liter bulk container QRR 010946 NOTE The latest version of the Material Safety Data Sheet MSDS of the used reagents can be found on our web site www rrmechatronics com 7 5 Warning screen End of day wash End of day wash Last End of day wash more than 12h ago End of day wash now Recommended This warning screen appears when the End of day wash was not done after the last sample run and the Starrsed Inversa has been idle or switched off for more than 12 hours Press ENTER to start the function This will ensure that the pipettes are cleaned thoroughly This function can also be started manually at a later time Starrsed Inversa Instructions For Use Page 57 Version 1 10 MRN 144 EN RR Mechatronics After starting the Starrsed Inversa a warning may appear on the screen stating that the last prime cycle was more than 12 hours ago Press ENTER to start the priming cycle Quick start up 7 6 Priming the fluid system To start the priming manually go to the Main menu and use the function PRIME The priming cycle takes ca 2 minutes to complete Page 58 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics Sample routine procedure 8 SAMPLE ROUTINE PROCEDURE This section explains the necessary procedures for preparation and processing of blood samples on the Starrsed Inversa 8 1 Sample Mixing To ensure that the blo
58. he serial number of the chip card 6 7 8 2 Menu Read service card AS Read service card gt gt lt lt Read service gt gt lt lt Read service card gt gt Type Continue Do NOT remove card SN 1234567899 Busy please wait Password E AH YES After reading a service card the following information is shown This is the code letter for the type of chip card SN This is the serial number of the chip card Enter the required password for the inserted type of service chip card and press ENTER Wait until the display shows OK Starrsed Inversa Instructions For Use Page 37 Version 1 10 MRN 144 EN RR Mechatronics User interface 6 8 Lab Supervisor menu section Lab Supervisor functionality can be accessed with chip card type S Only the additional supervisor functions and submenus are explained in this section For the standard user menu refer to the User menu section on page 27 6 8 1 Menu 2 Patient pos data Patient pos data Patient data Position data Print data Print raw data Send data wh Delete data m ESC BE SELECT 6 8 1 1 Menu Delete data Delete data 1 Delete pipet data 2 Delete hist data SELECT Function 1 DELE
59. hen the MECHATRONICS 01 or MECHATRONICS 02 protocols are used the Sample code or Sample type flag is set accordingly to mark the QC samples e OFF Default setting Results will not be send to LIMS data is only available on the Starrsed Inversa 6 AUTO REMOVE LINK e ON Default setting The link between Starrsed Control Sample ID and Lab ID will be deleted after a useable result has been reported for this particular lab ID For each QC sample a new link must be created This link will stay active if there is no result or a general ESR error is generated This setting is useful when the lab issues a new and unique Lab ID for every QC sample e OFF The link will be available until its deleted manually This could be useful when using a general Lab ID for QC monitoring Only in case of a new batch of Starrsed Control a new link has to be created Starrsed Inversa Instructions For Use Page 43 Version 1 10 MRN 144 EN RR Mechatronics User interface 7 LINKED ID s A maximum of five linked ID s can be maintained To enter a new link scroll to an empty position or press New lt lt Linked ID s gt gt Starrsed Control ID Lab ID X Delete m New 1 5 If the Lab ID is numeric 1 Place the Starrsed Control tube on sample position press Enter to scan the barcode 2 Enter the Lab ID press Enter to confirm The link information is showed on the screen the link is activated I
60. hen the instrument is running it is not allowed to e Open and remove safety covers e Touch moving parts e It is not allowed to give access to the instrument to a non authorised person at any time e Whenever it is likely that safety protection has been impaired the instrument must be made inoperative and be secured against any unintended operation The matter should then be referred to qualified technicians e Safety protection is likely to be impaired if for example the instrument fails to perform the intended measurements or shows visible damage or unusual smells smoke liquids are flowing out 3 1 Safety warning When there was an incident with the Starrsed Inversa which caused damage to the instrument please notify your superior and your local equipment dealer before you continue using the instrument Example collision with a moving object or a person e Something falling on the instrument e Liquids spilling into the instrument Page 20 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics Installation 4 INSTALLATION The instrument must be unpacked installed and checked by a trained engineer prior to first operation 5 LABELS AND STICKERS 5 1 Stickers for the onboard reagents bottles STAR amp SED STARASED STAR amp SED WASTE DILUENT X CLEAN 2500 1000ml 1000 Afval Verdunningsvloeistof Reinigingsvloeistof Abfall Verd nnungsl sung Reinigungsl s
61. ime now Recommended This warning screen appears when the Starrsed Inversa has been idle or switched off for more than 12 hours Press ENTER to start the function This will ensure that the fluid lines are correctly filled with diluent This function can also be started manually at a later time Page 24 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics 6 4 Warning screen End of day wash End of day wash Last End of day wash more than 12h ago End of day wash now Recommended User interface This warning screen appears when the End of day wash was not done after the last sample run and the Starrsed Inversa has been idle or switched off for more than 12 hours Press ENTER to start the function This will ensure that the pipettes are cleaned thoroughly This function can also be started manually at a later time 6 5 Menu structure Main menu Starrsed Inversa Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN SAMPLE MODE Patient pos data End of day wash Prime Settings Service Card amp Credits 55 Lr _ SELECT Page 25 RR Mechatronics User interface 6 6 Menu structure User and Supervisor Overview Starrsed Inversa Note The User options are shown in this colour The supervisor options are shown in this his colou
62. ions Page 126 RR Mechatronics Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics 20 INDEX A Aborting the sample sequence 61 Accessories kit 19 Air bubbles 86 Analyser 77 Analyser ERROR 73 Appendix Article reference list Starrsed Inversa 19 90 Appendix Default settings Starrsed Inversa 103 Appendix Error list Starrsed Inversa 92 Appendix Maintenance schedule Starrsed Inversa 105 Appendix Tube connection Starrsed Inversa 102 Appendix Warning list Starrsed Inversa 101 APPENDIX FOR STARRSED INVERSA 89 Aspect 76 Aspirating the sample 60 Automatic rinsing of the sample system 61 B Bidirectional 125 CE Mark Starrsed Inversa 18 Check list 54 Chip card system 14 Chip card type A to E 15 Chip card type Q 15 Chip card type S 15 Chip card type 15 Citrate mode 125 Column height error 83 D Daily 80 DATA SAFETY MANAGEMENT 79 Diluent QRR 010931 21 57 Dilution principle 10 Disabling a pipette 84 Document history overview E EDTA mode 125 End of day wash procedure 66 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN Index ESR 125 ESR Error and Warning code messages 74 Expected value range 62 Explanation of available documentation 9 F Fill errors during sampling 61 Foam in column
63. ition data 28 Menu Print 28 Menu Print raw data 29 Menu Print settings 33 Menu Printer results 46 Menu Protocol 47 48 49 Menu Read barcode 52 Menu Read service card 37 Menu Replace pipette 52 Menu Result at 45 Menu Send data 29 Menu Sensor status 51 Menu Set waste sensor 34 Menu Software versions 35 Menu structure Main menu Starrsed Inversa 25 Menu structure User and Supervisor Overview Starrsed Inversa 26 Menu Tcorr 41 Menu Temperature 41 Menu Valve control 51 Monitoring measurement quality with Starrsed Control 62 MRN 125 MSDS 125 N Navigating through the menus 23 air bubble random in pipette 87 Page 128 RR Mechatronics P Placing sample tubes on the needle system 59 Power failure 79 Power up sequence 54 Priming the fluid system 58 Printer paper replacement 55 Protocols 69 Q QC Error messages 64 QC Result analysis 64 QC Results 63 64 QC Settings 42 64 QUALITY CONTROL 62 Quality control procedure 63 Quality control trouble shooting 65 88 QUICK START UP 54 R Reagents 83 Replacing a pipette 85 Report 30 Minute mode 72 Report 60 Minute mode 71 REPORTING 69 Reporting range 75 Result Printout 70 Results at limit errors 46 75 S Safety warning 20 Sample Mixing 59 SAMPLE ROU
64. liability of the instrument the maintenance procedures must be strictly followed All procedures are based on a number of samples Maintenance levels Work instruction Daily on page 80 WI 400 Daily page 108 Weekly on page 80 406 Weekly on page 109 Level 4 maintenance WI 404 Level 4 maintenance on page 110 on page 81 Level 3 maintenance WI 403 Level 3 maintenance on page 117 on page 81 Level 1 2 maintenance available to be performed by a trained service engineer WARNING Always be aware of the danger of infection especially during maintenance Take appropriate precautions There is blood involved and therefore a BIO HAZARD The purpose of the daily maintenance is to keep the instrument clean and contamination as low as possible 15 1 Daily See work instruction WI 400 Daily page 108 for a step by step procedure 15 2 Weekly The purpose of the weekly maintenance is to carry out the daily maintenance and additionally check for worn components See work instruction WI 406 Weekly on page 109 for a step by step procedure Page 80 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics Maintenance 15 3 Level 4 maintenance The purpose of level 4 maintenance is to carry out the daily the weekly maintenance and additional e Check the waste pump tube condition Replace the tube if it appears worn or leaking e Replace
65. licable for Starrsed Control used on Mechatronics ESR Starrsed instruments Starrsed Control is available in Abnormal range Level A Normal range Level N 9 2 Limitations Starrsed Control is to be used for Erythrocyte Sedimentation Rate testing only and shall not be used to control any other hematology procedure Starrsed Control shall not be used as a standard Starrsed Control should not be used past the expiry date Mechatronics as supplier of the Starrsed Control shall not be liable for any claimed damages arising from other than intended usage 9 3 Expected value range Starrsed Control is assayed for the Starrsed ESR analyzers The assayed mean values and expected ranges are derived from multiple analyses at different sites and on multiple instruments The values provided on the package insert and encoded in the tubes barcode are specific for this lot of product The lab should establish its own acceptable ranges Whenever the Controls fail to perform consistently within the acceptable ranges patient results should be considered invalid Contact your Starrsed instrument provider for assistance If results vary outside the specified assay ranges discard the tube and utilize a new tube If difficulties persist contact your supplier for further assistance and or instructions 9 4 Temperature correction The assayed values are based on an 60 minutes ESR with dilution and temperature correction Therefore the measure
66. machine NOTE BH The descriptions Line 1 to Line D in the following subsections are only for reference within this documentation These descriptions do not appear on the printout Which lines are actually displayed on the printout depends on the instrument settings and the printed result Page 70 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics Reporting 12 2 1 Report 60 Minute mode Column 1 Column 2 Column 3 Column 4 Line 2 pens 75 mm 1 CORT Line ESR 60 mm 1 Line Clear Line C 15 03 10 13701 Patient number 1234567890 Line1 ID 1234567890 60 minute ESR result in millimeters corrected for 18 C only in use if temperature correction is active ESR T Line2 75 mm 1H Not corrected 60 minute ESR result Line3 ESR 60 84 mm 1H Aspect clear hazy LineA Aspect Clear EDTA mode is On or OFF LineB EDTA ON ESR time 60 Starrsed Inversa Instructions For Use Page 71 Version 1 10 MRN 144 EN RR Mechatronics Reporting ESR TIME Actual sedimentation time in minutes LineC 15 03 10 13501 PALS Pipette number in eles Present time Presen this example pipette 15 date temperature Line D is used for error and warning messages and printed in reversed colours 12 2 2 Report 30 Minute mode Column 1 Column 2 Column 3 Column 4 Line 1 0 Line 2 Line4 ESR 30 42
67. mal results it should be considered to on the user setting samples willbe the acceptable assay range finished with QC Settings Check If this error persists check clean acceptable range instrument in QC settings E142 The uncorrected result is Consider QC The mean value is assayed with out of range but the result as correct temperature correction result is corrected result is within correct Use general setting temperature correction TCorr ON E143 The uncorrected result is Consider QC Check acceptable range in QC settings but the result as not If this error persists check clean corrected result is out of correct range instrument Take a new Starrsed Control sample normal samples will be Use general setting temperature correction TCorr ON finished Page 100 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics Appendix for Starrsed Inversa Appendix Warning list Starrsed Inversa REN Remark Possible cause E200 Warning No printer Check printer Printer malfunction e E201 Warning Printer cover Close cover e Cover open open P e Cover sensor malfunction e E202 Warning Out of paper Put in a new paper Out of paper roll sensor malfunction Warning Temperature Turn off printer Contact local service engineer problem E204 Warning Power supply problem Warning printer buffer full
68. mm h Line Aspect Clear Line EDTA ON ESR time 3 Line 15 03 10 1 381 24 215 Line3 5 60 84 mm 1h 0 Line D Patient number Line1 ID 1234567890 60 minute ESR result in millimeters corrected for 18 C only in use if temperature correction is active db Line 2 75 mm 1H corr Page 72 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics Reporting Not corrected 60 minute ESR result Line3 ESR 60 84 mm 1h Not corrected 30 minute ESR result only in use if 30 minute mode is active Line 4 ESR 30 42 mm h Aspect clear hazy Line Aspect Clear EDTA mode is On or OFF LineB EDTA ON ESR time 30 ESR TIME Actual sedimentation time in minutes LineC 15 03 10 13801 22 215 Pipette number in The present time this example pipette 15 date temperature Line D is used for error and warning messages and printed in reversed colours 12 2 3 Analyser ERROR Error messages can be found on the printout at the bottom line in reversed colours All other lines of the report are removed accept the line with patient ID and line B and C If errors are found during the measurement the Starrsed Inversa will give an audible alarm Starrsed Inversa Instructions For Use Page 73 Version 1 10 MRN 144 EN RR Mechatronics Reporting 12 2 3 1 ESR Error and Warning code messages No errors No cells pla
69. n the needle unit and press the ENTER key The detected barcode is displayed on the screen in this example 1234567890 6 8 3 6 Menu Replace pipette lt lt Replace pipet gt gt Current pos 8 Input ES This function can be used to move a particular pipette to the door opening when the pipette needs to be replaced Enter the number of the pipette and press ENTER 6 8 3 7 Menu Empty pipette This function can be used to empty a pipette that may have remained filled due to an error condition The function is performed on the pipette that is currently at the nozzle position Press ENTER to confirm the selection and start the function lt lt Empty pipet gt gt Are you sure E Page 52 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics User interface Press ENTER to continue NOTE To empty another pipette use function CARoUsEL M33 in the menu MOTOR CONTROL to move the pipette to the nozzle position and then use function EMPTY PIPET 6 8 3 8 Menu Empty all pipets This function can be used to empty all pipettes due to an error condition Press ENTER to confirm the selection and start the function lt lt Empty all pipets gt Samples will be lost Are you sure E Press ENTER to continue 6 8 3
70. nes and computer systems The following protocols can be selected for data transfer to the Laboratory data processor computer No Serial output MECHATRONICS 01 bidirectional MECHATRONICS 02 unidirectional Compact bidirectional Compact unidirectional Protocol Sysmex R 3500 Protocol Sysmex R 3500 unidirectional Or TRES Starrsed Inversa Instructions For Use Page 47 Version 1 10 MRN 144 EN RR Mechatronics User interface The protocol can be set in menu SETTINGS PROTOCOL After selecting a protocol save the new settings by pressing the ENTER key CHECKSUM 30 MINUTE OUTPUT Serial 2 Not selectable Not selectable Not selectable Serial 3 Not selectable Selectable Not selectable Serial 4 Selectable Not selectable Selectable Serial 5 Selectable Selectable Selectable 6 8 2 14 Menu Baudrate Baudrate Baudrate 9600 m ME Select Use the ARROW DOWN ARROW keys and select the required Baud rate 2400 4800 9600 19200 38400 8 N 1 Then press ENTER to save the new setting 6 8 2 15 Menu Checksum Checksum SS Not applicable m select Note This setting is only applicable if the output protocol is set to Compact unidirectional or Compact bidirectional See Menu Protocol on page 47 Page 48 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechat
71. nformation Ps QC result with ESR error no ESR Result is given e Check general ESR data see ESR Error e Check sample tube volume e Take a new Starrsed Control sample QC result with ESR warning ESR Result is given e Check general ESR data general ESR Warnings e Check Result at limit setting CONTROL OUT OF RANGE This error indicates a general a new Starrsed Control ESR error or a QC result error Sample normal samples will be after QC sampling finished e If this error persists check clean instrument Starrsed Inversa Instructions For Use Page 87 Version 1 10 MRN 144 EN Trouble shooting RR Mechatronics General errors Extra information POCHE Barcode is not accepted Barcode cannot be read Data is incorrect QC sample is not accepted and Starrsed Control ID is not known not performed Linked Lab ID is not accepted e Check barcode Check barcode e Link Starrsed Control ID to a Lab ID A Lab ID can be linked to Use another Lab ID Starrsed Control ID Deviating results Extra information CONES The measured control values change abruptly up or downwards Systematic QC errors with a shift in control values QC results are out of range Do not compare 30 minute method with 60 minute method result The calculation method can give some deviation in the general QC results statistics The measured control values change gradually upwards or downwards Systematic QC er
72. ns For Use Version 1 10 MRN 144 EN RR Mechatronics Sample routine procedure 8 4 Aborting the sample sequence If a clean pipette is not available yet and sampling has not started yet it is possible to abort the sample by pressing the CANCEL key NOTE As soon as the tube starts to move over the needle it is not possible to cancel the aspiration sequence 8 5 Automatic rinsing of the sample system After each aspiration the sample needle sample tubes and fill nozzle are automatically washed with diluent 8 6 Fill errors during sampling After filling the sample into the pipette the quality of the aspiration is checked by pre measuring the pipette The following parameters are checked e the column height e the usage of diluent possible air bubbles In case of air detection at the bottom of the pipette E20 FiLL ERROR is shown on the display This error indicates dilution problems or insufficient sample flow If there are other deviations a beep will sound after the check and an ESR Error or warning is reported Starrsed Inversa Instructions For Use Page 61 Version 1 10 MRN 144 EN RR Mechatronics Quality control 9 QUALITY CONTROL 9 1 Monitoring measurement quality with Starrsed Control Starrsed Control is an in vitro diagnostic quality control material to monitor the accuracy and precision of Erythrocyte Sedimentation Rate ESR instruments and procedures This instruction is only app
73. nversa OFF 4 Switch the Starrsed Inversa ON When the error occurs again switch OFF all units and call for service 16 2 Reagents Check the expire dates of the reagents regularly Do not use the reagents if expired Note If expired reagent has been used accidentally the results obtained with these reagents may only be used when the expire date was not exceeded more than 30 days DILUENT is sensitive for bacterial growth The solution should be discarded if it becomes turbid or infected When using the small onboard containers clean the DILUENT container thoroughly with 1096 Na hypochlorite Make sure that the container has been thoroughly rinsed after cleaning 16 3 Column height error When there is a column height error detected the software assumes that a pipette is leaking and disables the future use of this pipette Page 82 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics Trouble shooting 16 4 Sampling not allowed now If no chip card is inserted in the card reader and the sample mode is started by pressing 1 Sample mode the following screen is shown lt lt SAMPLE MODE gt gt Not allowed now No card present Es e Press ESC to return to the main menu e Insert Q chip card or A to E chip card e Press 1 Sample mode 16 5 Leaking pipettes Pipettes may be leaking if the plunger tip is worn 16 5 1 Disabling a pipette
74. o test the function of the motors or to move the associated unit to a particular position for service and maintenance reasons Select the required motor and use the ARROW DOWN or ARROW UP keys to switch the motor ON or OFF N Page 50 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics User interface 6 8 3 2 Menu Valve control Service Noz NdI V23 Dil Cln V24 Venting V25 Blood V26 Diluter V27 C ESC mE SELECT These functions can be used to test the function of the valves for service and maintenance reasons Select the required valve and use the ARROW DOWN ARROW UP keys to switch the valve ON or OFF A 6 8 3 3 Menu Sensor status lt lt Sensor status gt gt Blood detec 126 Meas head 40 Temperature 20 Pos sensor 235 Waste sensor 200 Note Waste sensor Value range 130 240 6 8 3 4 Menu Measure pipette Press the ENTER key to measure the pipette that is currently in front of the measure unit The result is printed as graph on the build in printer Starrsed Inversa Instructions For Use Page 51 Version 1 10 MRN 144 EN RR Mechatronics User interface 6 8 3 5 Menu Read barcode lt lt Read barcode gt gt Barcode 1234567890 To check the function of the barcode reader place a sample tube with barcode i
75. od cells are evenly dispersed throughout the sample the sample tube must be mixed immediately before placing it in the sampling unit This can be done either manually or by using a sample tube mixer that inverts the tubes The sample tube must be fully inverted at least 8 times Do not shake the sample NOTE Ensure that the sample tube contains at least 2 ml of whole blood tt 8 2 Placing sample tubes on the needle system After mixing insert the sample tube into the needle assembly with the cap downwards and the barcode label pointing towards the instrument 1 8 2 1 Sample tubes with barcode 1 Start the SAMPLE MODE 2 Push the START key 3 Check that the scanned ID number appears on the display 4 ID number does not appear on the display the barcode could be read Starrsed Inversa Instructions For Use Page 59 Version 1 10 MRN 144 EN RR Mechatronics Sample routine procedure 1 Rotate the sample tube a little bit and push the START key again Or 2 Enter the ID manually as described in the next section NOTE The sampling may not start immediately if a clean pipette is not yet available but will start automatically when a clean pipette is available within 90 sec To prevent the aspiration of a not properly mixed sample sampling will not start automatically when it takes longer than 90 sec for a pipette to become available The operator must then remix the sampl
76. ons For Use Version 1 10 MRN 144 EN RR Mechatronics Instrument description 2 1 1 Chip card type A to E Chip cards of the types A to E are used to operate the instrument in a pay per test scheme The chip cards contain a certain amount of credits units How many tests can be performed with this amount of credits depends on the configuration which is made by the local Starrsed Inversa dealer The following amounts of credit units are available RE 5 5000 gt NOTE UU Available card types and amount of credit units may be subject to changes The total amount of credit units on the chip card is transferred to the Starrsed Inversa at once and the chip card is then rendered void It is not possible to use the same chip card to transfer credits to more than one instrument This type of card is dealer dependent The instrument only accepts chip cards of the dealer to which the instrument is configured 2 1 2 Chip card type Q Chip cards of type Q are used to operate the instrument in ownership without credit limitations and can only be used on instruments which are configured to accept the Q chip card 2 1 3 Chip card type S Chip cards of type S Supervisor card are used by lab supervisors to grant them access to important instrument settings When this type of chip card is inserted in the card reader a PIN code must be entered to unlock the protected menus 2 1 4 Chip card type T Chip car
77. oom temperature Set T CORR Lab supervisor ON ON Set DST Lab supervisor OFF OFF Set RESULT AT LIMIT Lab supervisor ON ON PRINTER RESULTS Lab supervisor ON ON Set system DATE TIMET Lab supervisor 00 00 00 Time Set system DATE TIME Lab supervisor 01 01 1998 Date Select LANGUAGE Lab supervisor English English Adjust temp Sensor supervisor 18 3 18 3 ESR TIME MIN Lab supervisor 60 Min 60 Min PROTOCOL Lab supervisor NO SERIAL OUTPUT NO SERIAL OUTPUT Set BAUDRATE Lab supervisor 9600 9600 30 MINUTE OUTPUT Lab supervisor OFF OFF CHECKSUM Lab supervisor OFF OFF ACK NACK Lab supervisor OFF OFF BARCODE READER Service Keyence Keyence MAX NEEDLE CURRENT Service 180 180 SET PISTON POSITION Service 900 890 Note Software Default Settings are the values that are set when the software is reset by using the key board function FACTORY SETTINGS Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN Page 103 RR Mechatronics Appendix for Starrsed Inversa Page 104 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics Appendix for Starrsed Inversa Appendix Maintenance schedule Starrsed Inversa Maintenance schedule Starrsed Inversa Sample volume 200 Per day Daily Level 4 Level 3 Level 2 Level 1 amount Daily Sample 150 Ft Clean outside of the aspiration needle End of day wash procedure Wash all pipettes heck
78. orted local service engineer E75 Flash memory erased Check settings e Flash memory malfunction Default settings are loaded Checksum error Default Check settings Calculated checksum does not match settings are loaded with the checksum stored in EEPROM only allowed when the pipette is empty e Flash memory malfunction E77 Number not assigned E78 052401 not detected If this error occurs repeatedly contact local service engineer e Serial number chip malfunction Communication error with If this error occurs repeatedly contact DS2401 local service engineer Serial number chip malfunction Page 96 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics SPI error Write mode error Sector protection error Pipette data write error Patient data write error Patient write read index write error Block erase error Pipette data corrupt Settings write error Card amp Credit data write error Number not assigned Number not assigned Number not assigned E94 Number not assigned E95 Number not assigned Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN E80 E81 E82 E83 E84 E85 E86 E87 E88 E89 E90 E9 E9 E93 E94 E95 Pipette data erase error Appendix for Starrsed Inversa If this error occurs repeatedly contact local service engineer e Flash memory malfunction If this error o
79. ory Error history 1 Show error history 2 Print error history 3 4 5 6 7 2 Ese SELECT Page 34 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics User interface Menu SHOW ERROR HISTORY lt lt Show error history gt gt 01 08 2013 15 12 00 31 07 2013 Error 18 1 31 86 ug The first row shows the current date and time The third row shows the date and time when the displayed error occurred Use the ARROW DOWN or ARROW UP keys and select the next error code Menu PRINT ERROR HISTORY lt lt Print error history gt gt Cont i nue Press ENTER to start the function The error history is printed on the build in printer 6 7 7 2 Menu Software versions lt lt Software versions 22 Main Vx xx Slave 10 VX xx Display VX xx iU ESC Starrsed Inversa Instructions For Use Page 35 Version 1 10 MRN 144 EN RR Mechatronics User interface 6 7 7 3 Menu Display S N lt lt Display S N gt gt S N 000123456789 E The displayed number is the instrument security number which is a security feature associated with the chip card system NOTE This security number is not the same as the serial number of the instrument The serial number is
80. ppears in the sample data record at line A The following 4 codes are defined 0 Sample is clear Sample is Hazy 10 1 2 Sample is Hazy 25 3 Sample is Hazy 25 Starrsed Inversa Instructions For Use Page 77 Version 1 10 MRN 144 EN RR Mechatronics Inversa system messages 13 INVERSA SYSTEM MESSAGES 13 1 System messages During normal operation the following System messages may occur 1 Waiting tube e filled pipette is at the measuring position before the elapsed time has finished and the operator is ready to fill the next pipette the Waiting tube message will be displayed continue the sample loading sequence the operator must wait until the pipette at the measuring position has been measured 2 Printer failure e Check paper quantity e Note data will be stored in the buffer and can be printed afterwards 3 Heagents level empty message e All reagent bottles have level detectors the display shows an error that indicates which reagent bottle s is are empty e Prepare new reagent as described in section Quick start up 4 Waste bottle full message or No waste bottle message e The waste container also has a level detector If a waste error is shown on the display the Starrsed Inversa will stop filling and cleaning pipettes until a new or empty container has been installed Preferably replace it with a cleaned one e Press ESC to clear the error e
81. r Note Software version Main 2 04 Slave 1 23 Display 2 19 1 SAMPLE MODE 2 Patient pos data 7 Delete data 1 Delete pipet data 2 Delete hist data 3 End of day wash 4 Prime 5 Settings t 1 30 min method 2 EDTA mode 3 Temperature 4 Tcorr 5 QC Settings 1 Use assay range 2 Custom NORMAL range 3 Custom ABNORM range 4 QC request to LIMS 5 QC result to LIMS 6 Auto remove link 7 Linked ID s Carousel position Next 1 DST 2 Result at limit 3 Printer results 4 Date Time 5 Language 6 ESR time min 7 Next 1 Protocol 2 Baudrate 4 Checksum 5 ACK NACK 6 30 minute output 7 Next 5 Settings Contd 1 Set piston position 2 Set blood sensor 3 4 Barcode reader 5 Max needle current 7 Next 1 Factory settings 1 Motor control 1 Waste M34 2 Meas M28 3 Nozzle M29 4 Filling M30 5 Needle M31 6 Gripper M32 7 Carousel M33 2 Valve control 1 Noz Ndl 23 2 24 Venting V25 4 Blood 26 5 Diluter V27 Sensor status Measure pipet Read barcode Replace pipet Next Empty pipet Empty all pipets Empty sample pipets 1 Card amp Credits 1 Load credits 2 Read service card 3 Print credit status Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics User interface 6 7 User menu section User functionality can be accessed with all types of Chip cards 6 7 1 Main menu SAMPLE MODE Patient pos
82. reading darkest 100 and the lightest 0 96 absorption respectively By definition the levels are 87 5 Cells plasma separation 75 0 detection 50 0 Meniscus detection 25mm hazy 10 25 mm 25 hazy lt 10 mm 10 dea lt 3mm 3 VN 90 z 70 clear hazy lt 10 mm 60 2 gt 50 E 40 out off 9 305 measure arca 20 10 Loo LAE I 0 so 100 150 200 250 column sodimentation 110mm height Graphic showing typical absorption values of a sample The sedimentation value is the distance in millimeters between the cells plasma level 87 596 absorption and the meniscus If there is no haze the absorption drops quickly to a value below the 75 level If the distance between the 87 5 and the 75 level is less then 3mm the report will state CLEAR If the distance between 87 5 and 75 level is more than 3mm then the report will state HAZY Depending on the length of the hazy area three classes of haziness are reported Page 76 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics Reporting Length of Reported area class Hazy reports are shown when the change from the hazy level to the cell plasma separation level occurs not within a given distance The following code messages are reported in column 5 12 2 6 1 Analyser HAZY code messages This code a
83. rk Possible cause Numbernotassigmed p Number assigned 2 Carousel position error Set correct carousel Sensor value does not match with the position and or doa value stored in memory Learn positions 52 e Carrousel Position sensor malfunction Checksum error Default Check settings Calculated checksum does not match RAM settings are loaded with the checksum stored in RAM e Empty battery on main board RTC 051302 malfunction ES Number not assigned ass E6 Internal 12C communication If this error occurs repeatedly contact error local service engineer Waste bottle full Empty waste bottle e Level sensor malfunction and clear error Warning Diluent bottle Fill Diluent bottle e Level sensor malfunction empty 9 Warning X Clean bottle Fill X Clean bottle Level sensor malfunction empty E11 Unknown status in cleaning Reset the instrument If this error occurs repeatedly contact routine local service engineer E12 Fatal error in cleaning Reset the instrument If this error occurs repeatedly contact routine local service engineer E13 Error in cleaning routine gt If this error occurs repeatedly contact aborted local service engineer E1 Unknown status in fill Reset the instrument If this error occurs repeatedly contact routine local service engineer E16 Fatal error in fill routine Reset the instrument If this error occurs repeatedly contact local ser
84. ronics 6 8 2 16 Menu ACK NACK User interface lt lt ACK NACK Not applicable E Select 4 Note This setting is only applicable if the output protocol is set to MECHATRONICS 02 unidirectional or Compact unidirectional See Menu Protocol on page 47 6 8 2 17 Menu 30 minute output lt lt 30 minute output Setting OFF select Note This setting is only applicable if the output protocol is set to Compact unidirectional or Compact bidirectional 6 8 3 Menu 6 Service Lab Supervisor Service Error history Software versions Display S N Bottle alarm OFF Next bM ESC BE SELECT Starrsed Inversa Instructions For Use Page 49 Version 1 10 MRN 144 EN RR Mechatronics User interface Next submenu Service Motor control Valve control Sensor status Measure pipet Read barcode Replace pipet Next ESC SELECT Next submenu Service Empty pipet Empty all pipets Empty sample pipets 1 2 3 4 5 6 7 m ESC BE SELECT 6 8 3 1 Menu Motor control Service 1 Waste M34 2 Meas M28 3 Nozzle M29 4 Filling M30 5 Needle M31 6 Gripper M32 7 Carousel M33 pm ESC BE SELECT l These functions can be used t
85. rors with a trend in control values QC results out of the range or nearly out of the range e Check clean instrument and perform a new QC sample e If these errors persist perform maintenance step Compare only results from one batch e If Lab ID is used check the linked Starrsed Control ID It is possible that a new batch is in use without changing to the new assayed mean value e Irregular or insufficient maintenance can cause unnecessary QC errors and ESR errors warnings Note QC Error messages are only shown and stored on the Starrsed Inversa and not send to LIMS QC result is given with the same general errors and warnings as a normal patient ESR result Page 88 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics Appendix for Starrsed Inversa 17 APPENDIX FOR STARRSED INVERSA Appendix section Starrsed Inversa Instructions For Use Page 89 Version 1 10 MRN 144 EN RR Mechatronics Appendix for Starrsed Inversa Appendix Article reference list Starrsed Inversa The Starrsed Inversa is delivered with a complete accessories kit BANG119000 This reference list is for article order numbers only the actual contents of the accessories kit may be changed without notice part number Description 00000000000 010041 plate basic BANGO20003 Plunger tip inversa sewe 7 BANGO29002 Inversa Westergren pipette BANGO030052 _ Pipette sealing ring BAN
86. rrsed ST Starrsed RS Starrsed RL and Starrsed ST are instrument names of RR Mechatronics Until 2014 the Starrsed ST was called Inversa 24M the Starrsed RS was called AutoCompact the Starrsed RL was called Interliner RR Mechatronics changed the product names to benefit better from the worldwide recognizability of the brand name Starrsed 1 3 Dilution principle When the Starrsed Inversa is operating in the EDTA mode the blood sample is diluted with sodium citrate during the aspiration process On the Starrsed Inversa the dilution is achieved through a mechanical link between the syringe on the diluter and the pipette piston The dilution ratio is 4 volumes blood 1 volume sodium citrate diluent accuracy 3 Page 10 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics 1 4 Sedimentation measurement principle Introduction The automatic reading of the Westergren sedimentation pipettes is carried out by moving an optical sensor along the pipettes While the sensor is moving a reading is made every 0 25 mm The sensor is reading the absorption of infra red light through the Westergren pipette filled with blood From these readings values at a number of absorption levels are determined All absorption figures are relative to the darkest and lightest reading darkest 100 and the lightest 0 96 absorption respectively By definition the levels are 87 5 Cells plasma separation 75 0
87. se Page 119 Version 1 10 MRN 144 EN RR Mechatronics Note Check if all 5 O rings QWLV050003 in place and or if applicable replace the O rings QWLV050003 Page 120 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics Replace Needle sealing block Open needle cover to get access to the needle Remove both Knurled screws Push the needle down friction possible Place screw in needle sealing block BANG049002 Starrsed Inversa Instructions For Use Page 121 Version 1 10 MRN 144 EN RR Mechatronics Pull needle sealing block out the needle guide block assembly Remove screw Place new Needle sealing block BANG049002 Stick the needle in the needle sealing block on the needle not completely through Be aware for biohazard Place the needle sealing block into the needle guide block Push the needle back upwards against the friction Page 122 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics Push needle up till it is lined up to the mounting fix position Place both Knurled screws Replace Needle cover After the assembling is finished the needle need to be set into the correct position in the needle sealing block Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN Insert an empty sample tube into the needle assembly Return to the main screen and go to the sampl
88. sma found No contents could be detected in the pipette ESR Probably gt 140 mm Extremely high ESR value Too many borders found Error More than three borders found possibly air bubbles Fill Error Air detected below blood column Column height nnn Warning Column height must be between 180 and 210mm nnn the actual column height Measure error Warning The down count is not equal to the up count from the measure head Bubbles on top Air bubbles on top of the ESR Limit error Error One of the following limits are out of the setting range ESR Time e Column height Page 74 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics Reporting 12 2 4 Results at limit errors When this option is set to YES and this limit error occurs results will be printed send to the LIMS When this option is set to NO and this limit error occurs the fields for 30 min ESH 60 min ESR and the temperature corrected ESR are filled with spaces and thus results are not printed send to the LIMS The error message in the error field line D indicates that at least one of the limits ESR time dilution rate or column height has been exceeded Together with the sedimentation time and dilution rate which are still printed at the usual position the operator analyst can see what caused the error and may or may not use the ESR values which are preserved in the error message Description of the error message L
89. ste error the waste container must be emptied The waste must be treated as potentially infectious biohazardous material and disposed of according to local regulations Preferably discard the complete waste container and replace it with a cleaned one Press ESC to clear the error Disclaimer Check your local environment rules about discharging the waste 11 1 Waste container 1 Unscrew the cap Starrsed Inversa Instructions For Use Page 67 Version 1 10 MRN 144 EN RR Mechatronics Waste disposal 2 Liftthe slider and take the waste container out of the compartment 3 Close the container with the provided cap 4 Install the empty container in the reversed order 5 Only for instruments with waste sensor BANG019015 In case of a new waste bottle Check the values of the waste sensor at Menu Set waste sensor A NOTE A If you are re cycling the waste container make sure that it is bleached and rinsed thoroughly Use only a waste container supplied by Mechatronics Page 68 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics Reporting 12 REPORTING The standard output form of the Starrsed Inversa is a printed report The Starrsed Inversa is also able to handle different types of protocols for communication with a HOST Communication can be bidirectional and unidirectional 12 1 Protocols A protocol is a set of rules governing the communication and th
90. t the bottom of the pipette results in Error 20 Page 86 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics Trouble shooting 16 7 Quality control trouble shooting Error messages I Remark Possible cause E140 The used Starrsed Control Check expiry Use a new batch of Starrsed Control is out of date date Check date time settings E141 Result is out of range the Take a new If results are continuously out of range applicable values for the Starrsed Control but the statistics show identical stable acceptable range depend sample normal it should be considered to on the user setting samples willbe the acceptable assay range finished with QC Settings Check If this error persists check clean acceptable range instrument in QC settings E142 The uncorrected result is Consider QC The mean value is assayed with out of range but the result as correct temperature correction result is corrected result is within correct Use general setting temperature correction TCorr ON E143 The uncorrected result is Consider QC Check acceptable range in QC settings within range but the result as not If this error persists check clean corrected result is out of correct range instrument Take a new Starrsed Control sample normal samples will be finished Use general setting temperature correction TCorr ON Screen messages Extra i
91. tarrsed Inversa confirmation or denial of sample requests C 19 1 1 1 2 Citrate mode is used for pre diluted samples collected in tubes with sodium citrate anticoagulant diluent The samples are not diluted on the Starrsed Inversa during aspiration The concentration of sodium citrate within the diluent solution in the tube should be 3 296 This is not to be confused with the required dilution rate of blood and diluent For example in a citrate tube with a total draw volume of 1 6 ml 2 5 volumes the amount of pre filled diluent must be 0 32 ml 1 volume If this information is not provided by the tube manufacturer it should be checked by the customer E 19 1 1 1 3 EDTA mode EDTA mode is used for undiluted samples collected in tubes with EDTA anticoagulant The samples are automatically diluted on the Starrsed Inversa during aspiration The usual amount of EDTA in sample tubes is 1 8 mg per 1 ml blood 1 ml of blood weighs ca 1060 mg and the concentration of EDTA is therefore 0 1796 and well within the requirements for the EDTA mode on this instrument Bidirectional Citrate mode 19 1 1 1 4 ESR ESR is short for Erythrocyte Sedimentation Rate It is the amount of sedimentation setting of erythrocytes red blood cells in a blood column during a specified time Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN Glossary of Terms H 19 1 1 1 5 Hazy A sedimentation is reported to be ha
92. the Pipette sealing and the nozzle O rings e Replace Needle sealing block See work instruction WI 404 Level 4 maintenance 110 for a step by step procedure 15 4 Level 3 maintenance The purpose of level 3 maintenance is to carry out the daily the weekly and level 4 maintenance and additional e Replace the pump tubing e Replace Disk filter See work instruction WI 403 Level maintenance on page 117 for a step by step procedure Starrsed Inversa Instructions For Use Page 81 Version 1 10 MRN 144 EN RR Mechatronics Trouble shooting 16 TROUBLE SHOOTING Occasionally small faults may cause major problems This chapter may help to solve the most common faults and explain why a specific problem occurs A lot of the problems or errors are due to a lack of maintenance Remember that this instrument operates with a considerable amount of whole blood virtually undiluted stores it in a pipette for one hour and then cleans pipettes for re use Therefore it is important to keep to the maintenance schedules It is recommended that trained service personnel checks and applies service to the instrument at least once a year 16 1 General error procedure Whenever an error occurs follow the instructions given in the Error list If no instructions are given follow this general procedure 1 Clear the error by pressing the ESC key 2 When the error is not cleared or the error occurs again 3 Switch the Starrsed I
93. the cardboard box pull the opening out of the box and fit the taps 2 Fill up the containers with the reagents 3 To remove the containers from the instrument first pull the slider all the way up then remove the bottle Page 56 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics Quick start up 7 4 1 Diluent QRR 010931 Sodium citrate diluent is used for the dilution of undiluted EDTA samples and for the automatic rinsing of the sample system between samples e Approximately 5 ml Diluent is used for each sample cycle The on board container for Diluent is a 1 liter plastic bottle Fill the container with Diluent from the 5 liter bulk container QRR 010931 The solution should be discarded if it becomes turbid If the Diluent does become turbid clean the Diluent container thoroughly with a 5 Na hypochlorite solution After cleaning rinse the container thoroughly with de ionized water Before refilling flush the Diluent bottle with a little Diluent from the bulk container NOTE BA The latest version of the Material Safety Data Sheet MSDS of the used reagents can be found on our web site www rrmechatronics com 7 4 2 X Clean QRR 010946 X Clean is a ready to use cleaning solution that is used for the End of day wash The solution removes residual proteins from the inner wall of the Westergren pipettes The on board container for X Clean is a 1 liter plastic bottle Fill the container wit
94. ube types Most commonly used brands types Sample tube types Closed tubes with concentric cap only Totallength 73 93mm Body diameter 11 5 15 5 mm diameter 13 18mm Barcode reader Barcode reader type 099 Reading capabilities Most common barcode labels Code38 ITF Industrial 2 or 5 CodaBar EAN UPC and CODE128 Data storage Battery back up memory Storage medium l Results and raw data of 896 samples Storage capacity Starrsed Inversa power requirements Fuse 20 x 5 mm Slow blow 230V 1 6 Amp Slow blow 115V 2 5 Amp Power consumption Standby 30 VA Maximum 100 VA Heat output Standby 16 Watt Full operation 30 Watt Starrsed Inversa Instructions For Use Page 17 Instrument description Starrsed Inversa environment Sound level Environment temperature Relative humidity Starrsed Inversa overall dimensions Dimensions Width Height Depth Weight without fluids Starrsed Inversa table size Table size recommended Width Depth 2 2 1 CE Mark Starrsed Inversa RR Mechatronics Less than 58 dBA 18 28 10 90 330 mm 770 mm 530 mm 23 kg 600 mm 750 mm The CE Mark is found on the Mechatronics instrument identification plate an illustration of which is shown below with explanations The instrument identification plate is fitted at the left side of the rear panel of the Starrsed Inversa D a won BANG 10 9000 866 SN wer 230 118 16 25 Expl
95. uction Removed check waste H E van Dijk 2011 401 pump tube condition from Appendix WI 401 e Appendices added Tube connections factory settings maintenance schedule Starrsed Inversa Instructions For Use Page 3 Version 1 10 MRN 144 EN 2011 manual explanations added for user interface RR Mechatronics Document Document history overview ee overview January Replaced Key card for Chip H E van Dijk 2011 card Attention markers for User Supervisor and Technician Included in menu descriptions 2010 1 01 Septembe New version Error Menu options added H E van Dijk r 2010 list August All e Manual started H E van Dijk 2010 Page 4 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics Contents CONTENTS 1 INTRODUCTION e 9 1 1 Explanation of available documentation 9 1 2 Starrsed line of ESR instruments 4 10 1 3 Dilution principle m rH nde 10 1 4 Sedimentation 11 2 INSTRUMENT DESCRIPTION uiae tunt ano ku tan este uana 12 2 1 Chip card 14 2 1 1 Chippeard type 15 2 2 Chip card
96. ung D chets Diluant tamponn Solution de nettoyage Scorie tamponata Soluzione detergente Desecho ae Soluci n limpiador Residuos Solu o limpiador A mechatronics mechatronics mechatronics These stickers are used on the onboard reagent bottles For more information about these bottles See sections e Waste disposal on page 67 e Diluent on page 57 X Clean on page 57 Starrsed Inversa Instructions For Use Page 21 Version 1 10 MRN 144 EN RR Mechatronics User interface 30 6 USER INTERFACE A ARROW UP key v ARROW DOWN key RR Ee Enter mechatronics omen a ENTER key 8 9 A Back 4 5 6 Space BACKSPACE ke v key 1 2 3 2 al B ESC key PS BB CANCEL CANCEL key Page 22 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN RR Mechatronics User interface 6 1 Navigating through the menus The main menu is displayed after start up The bottom line of the display shows which keys are valid in the context of the selected menu or function To start functions or access other menus you can either e Press the required row number on the keyboard The function or menu is activated automatically e Scroll to the required row using the arrow keys and press ENTER to activate The menus SETTINGS and SERVICE contain more functions than can be displayed on one screen To access the next screen you can either e Press number 7 on the
97. vice engineer E17 Fill timeout Check sample No blood detected within x seconds e Empty sample tube e Blood detection sensor malfunction Page 92 Starrsed Inversa Instructions For Use Version 1 10 MRN 144 EN N RR Mechatronics o Appendix for Starrsed Inversa E18 Error in fill routine gt If this error occurs repeatedly contact aborted local service engineer 9 sample tube detected Place sample tube Needle sensors malfunction E20 Error Check diluter diluent e Air detected below blood column Diluter malfunction Diluter valve malfunction Empty diluent bottle e Not enough blood in sample tube e Empty sample tube E21 Fill sensor error Check blood Blood detection sensor out of range diese sons Check for drops of liquid E23 Number not assigned E24 Number not assigned Filling motor could not go to home position Gripper is closed e Gripper must open Gripper sensors malfunction Not allowed to start Filling e Carousel home sensor malfunction motor Carousel is not at a defined position Filling motor could not go down all the way Gripper is closed e Gripper must be open e Gripper sensors malfunction Number not assigned Number not assigned Carousel could not turn Gripper is closed E32 Carousel could not turn Measure head not at home position E29 E30 E31 e Gripper must be open e
98. xpected value rante unsere per tn incuria 62 SE NMNE IM rules 62 9 5 Quality control DOGS E EE QUE DIM M ELA 63 Sb QC RSS US i ud ere pei sonent 64 9 6 1 QC Result 64 9 6 2 QG R E 64 10 TURN mm 66 10 1 End of day wash procedure 66 11 WASTEDISPOSAL aaan iue 67 Tide pact bnt iai 67 MN gicpee G X X XM 69 aimer Kei Esai Me uuu exte ee 69 12 2 Result Es 70 12 2 1 Report 60 Minute 71 12 2 2 Report 30 Minute enne 72 12 2 3 Analyser ERROR bbb foren een mE 73 12 2 3 1 ESR Error and Warning code 74 12 2 4 Results at limit GITOLS iue CO UR RN RUNI MD nes PERI EM IU 75 12 2 5 Reporting rang reper O
99. y bisce victa 36 p 7 4 Menu Bottle alarm OFP itt etta 36 6 7 8 Menu 7 Card amp Credits 36 6 7 8 1 Menu Load credits pra Sieb nu ec EE EK EHE 37 6 7 8 2 Menu Read service 37 6 8 Lab Supervisor menu SUME 38 6 8 1 Menu 2 Patient pos uec iens bul s sten 38 6 8 1 1 Menu Delete 38 6 8 2 Menu 5 Settings 39 6 8 2 1 Menu SD min method cuoco eiie ER riori eun tip 40 6 8 2 2 Menu EDTA mode ccm 41 6 8 2 3 Menu Temperature 41 68 24 Menu COn T m 41 6 8 2 5 Settings C 42 6 8 2 6 Menu Carousel position 45 68 27 121113 53 Hd duit 45 6 0 2 0 Menu Resultat LU bun KIM 45 6 8 2 9 Menu Printer esulls eecs ores V Micra 46 6 8 2 10 Menu Date Time 46 6 8 2 11 Menu 1 nnne nnn nnne 46 6 8 2 12 Menu ESR time ccce utet rins ets reina 47 pas rs
100. zy when the boundary between blood plasma and erythrocytes can not be defined clearly 19 1 1 1 6 Host In this manual the term HOST is used to indicate the computer system and associated software LIMS that provides the sample management for the laboratory 19 1 1 1 7 IVD IVD is short for In Vitro Diagnostic This kind of diagnostic is performed on biological samples in a test tube or more generally in a controlled environment outside a living organism n vitro means in glass in Latin M 19 1 1 1 8 MRN is short for Master Registration Number It is used as an identification number for any manual for Mechatronics products 19 1 1 1 9 MSDS MSDS is short for Material Safety Data Sheet In this type of MSDS all kind of important data can be found on reagents T 19 1 1 1 10 Temperature correction The sedimentation of blood cells is a temperature dependent process To achieve comparable results temperature correction should always be used The ESR results are then corrected to the value they would have been at the standard temperature of 18 3 Page 125 Glossary of Terms U 19 1 1 1 11 Unidirectional Unidirectional communication means that there is only one way communication from the Starrsed Inversa to the HOST Only sample results and result related messages are send W 19 1 1 1 12 WI Wl is short for Work Instruction and is used with an index number for a range of work instruct

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